Introduction

The spinal column, also known as the columna vertebralis or colloquially as the backbone, is the central load-bearing element in the skeletal system. It supports the body and enables an upright posture. It represents our center of rotation, making motion sequences to different directions possible. The Spine is not just the boney core, it also connects all other parts of the skeleton together. In addition, the vertebral or spinal canal encloses and protects the sensitive spinal cord that lies within it. Changes to the complex spine system may lead to impaired motion and causes severe pain. Surgical procedures on the spine are among the most frequently performed operations. A surgical procedure is often associated with pain, anxiety and limitations in your daily movements.

With our patient information we would like to tell you about different treatments for persistent symptoms in the spine.

Important information: Please keep in mind that SIGNUS Medizintechnik GmbH just provides general information about the treatment. Specific questions can only be answered by your doctor. SIGNUS assumes no liability for wrong indication or medical malpractice.

Patient information

SIGNUS Products

ROTAIO – Cervical Disc Prosthesis

Download PDF version: ROTAIO

Dear Patient,
Changes to the spine due to wear or disease are often accompanied by pain that can greatly affect the quality of your life. In this brochure we would like to tell you about a the treatment for persistent symptoms in the neck (cervical spine).

The cervical spine
The spine is an extraordinarily complex system of bones, cartilage, muscles and nerves, that has both static and dynamic functions. In addition it protects the spinal cord that lies within it. The cervical spine begins at the base of the scull (occiput) and consists of 7 small bones, called the cervical vertebrae: these (with the exception of the first two vertebrae) are joined firmly together by intervertebral discs. These discs consist of a firm ring enclosing a jelly-like core. The perfect interplay of the ring and core stabilises the cervical spine and, at the same time, allows a controlled range of movement between the vertebral bodies.

Treatment of intervertebral disc disease
Often these symptoms can be treated by conservative methods (medicines, physiotherapy, etc.). However, if the symptoms are not resolved or adequately eased, then an operation may become necessary. This surgery involves removing the disc bulge and any bony spurs in order to relieve the pressure on the compressed nerves and the spinal cord. To ensure lasting relief, this section of the spine may be stiffened (fused). Your surgeon may use autologous bone or special implants to achieve this. In some cases your surgeon might decide to also implant an additional fixating plate. This plate is placed in front of the cage and fixated in the adjacent vertebrae with two screws above and two screws underneath the treated disc. Fusion can lead to excessive stress on the adjacent segments, which accelerates the natural ageing process. This may require further fusion surgery. For several years now, attempts have been made to develop surgical treatments that prevent wear caused by stress on adjacent segments and preventing their further degeneration, but instead ensure that natural mobility is maintained. A disc prosthesis serves as a replacement for the removed disc and ensures normal cervical spine function as far as possible. It is not possible to implant a prosthesis in every patient. Severe degenerations in the cervical spine area, poor bone quality (osteoporosis), but also inflammatory processes in the spine, fractures, or tumours are some of the diseases that can make it impossible to use a prosthesis. Your surgeon will advise you in detail.

The Operation with ROTAIO®
Your surgeon gains access to the spine through a small incision in the front of your neck. The wound might be spread open using a retractor system. Next, the diseased disc and other compressing structures such as bony spurs are removed in order to relieve nerves and the spinal cord. Then, the ROTAIO® implant is positioned into the available space and the wound is closed.

After the Operation
An operation on the cervical spine is generally not a major procedure and the ROTAIO® implant is immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About ROTAIO®
ROTAIO® is a disc replacement implant for use in the cervical spine and serves as motion preservation. The parts of the ROTAIO® prosthesis that glide on one another are made from a cobalt-chrome alloy. This metal meets the most stringent demands regarding stress and, for that reason, has been used successfully for many years for artificial joints such as the hip and knee. In general, they are not explanted again but remain in the patient. The implants are available in various footprints and heights to enable adaption to different patient anatomies.

ROTAIO® Material
The implant is made of the following materials:
• Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
• Cobalt-chrome-molybdenum alloy as per ASTM F 1537 / ISO 5832-12
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
Non-clinical trials demonstrated that the ROTAIO® implant is ‘MRI conditional’. A patient with this implant can be safely examined in an MRI environment that complies with the following criteria:
• Static magnetic fi eld strength of 1.5 T
• Maximum spatial magnetic fi eld gradient of 5.3 T/m
• Maximum mean whole-body specifi c absorption rate (SAR) stated by the MRI system of 3.9 W/kg
Under these examination conditions a temperature increase in the implant of max 3.1° C (1.5 T) can be expected during a continuous examination over 15 minutes.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Wear or breakage of implant components
• Temporary or permanent noise production
• Pain or recurrent pain

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening arm or leg pain
• Any new or worsening weakness in your arms or legs
• Any new pins and needles or numbness in your arms or legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing neck pain
• Difficulties swallowing
• Problems with breathing

If you experience any serious incident in relation to ROTAIO®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

Important information: Please keep in mind that SIGNUS Medizintechnik GmbH just provides general information about the treatment. Specific questions can only be answered by your doctor. SIGNUS assumes no liability for wrong indication or medical malpractice.

ATHLET – Cervical Vertebral Body Replacement

Download PDF version: ATHLET

Dear Patient,
Destructive damage of the vertebral body, such as that caused by tumours, fractures or inflammations, can greatly affect the quality of your life. In this brochure we would like to tell you about the treatment of these damages of the cervical spine.

The Cervical Spine
The spine is an extraordinarily complex system of bones, cartilage, muscles and nerves, that has both static and dynamic functions. In addition it protects the spinal cord that lies within it as well as exiting nerves and vertebral arteries, that supply blood to the spinal cord, brain stem and cerebellum. The cervical spine begins at the base of the scull (occiput) and consists of 7 small bones, called the cervical vertebrae: these (with the exception of the first two vertebrae) are joined firmly together by intervertebral discs. These discs consist of a firm ring enclosing a jelly-like core. The perfect interplay of the ring and core stabilises the cervical spine and, at the same time, allows a controlled range of movement between the vertebral bodies. The vertebral body consists of a soft core (spongiosa) and a hard layer of bone (cortical bone) and form the weight-bearing part of our spine.

Destructive Damage of the Cervical Spine
The individual vertebrae in the spinal column are made up of the vertebral body, the spinous process and the vertebral arch. Like all other bones in the body, these structures can also break (fracture) – whether due to a fall or an accident or a bone density decreases with age (osteoporosis or thinning bones). Bone fractures can heal again. Only if the fracture is unstable, parts of the bone or bone splinters can jeopardise the spinal cord or the nerves. A spinal tumor is an abnormal mass of tissue within or surrounding the spinal cord and / or spinal column. These cells grow and multiply uncontrollagly, semmingly unchecked by the machanisms that control normal cells. Spinal tumors can be beign (non-cancerous) or malignant (cancerous). Primary tumors originate in the spine or spinal cord, and metastatic or secondary tumors result from cancer spreading from another site to the spine. The bony spinal column is the most common site for bone metastasis. The most common primary spine tumor (originated in the bony spine) is vertebral hemangiomas. These are benign lesions and rarely cause symptoms such as pain. Inflammatory disorders of the spine can be caused by a wide range of conditions, including arthritis, osteoporosis, and infection. Inflammation in the spine is rare but can be a significant source of pain and disability, especially if these hard-to-diagnose conditions go untreated. Ankylosing spondylitis, a form of arthritis in the spine, is one of the most common spinal inflammatory disorders.

Replacement of a Vertebral Body
If these symptoms cannot be resolved or adequately eased, then an operation may become necessary. In this case, the related vertebrae has to be removed and replaced by an implant so that the stability of the spine can be maintained. So that these implants are stably anchored, the top and bottom of the implant are placed directly on the neighbouring vertebral bodies and not the discs. Therefore adjacent discs are also removed, before placing the implant. When replacing a vertebral body there is always an additional fixation required. Therefore your surgeon might decide to also implant fixating screws (pedicle screws) from the back. Depending on the surgeons´ choice of access, this screw-rod-system will be implanted in one step with the implant. If a second step is needed, your surgeon might either way decide to turn you around during the operation to place the screws or to do these two steps in two different surgeries (within approx. two weeks).

The Operation with ATHLET®
Your surgeon gains access to the spine through a small incision in the front of your neck. The wound might be spread open using a retractor system. After the incision is made the surgeon clears the path to the spine and to the related vertebrae. The damaged vertebrae as well as adjacent discs will be removed. ATHLET® is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. In a next step the screw-rod-system is placed to increase stability. Depending on the symptoms and the damaged vertebrae, a one-level or multi-level fusion may be performed. New bone mass will gradually grow in and around the implant, creating a fusion which makes the area stable. This procedure will take away some flexibility in your spine, but most patients do not notice.

After the Operation
After the vertebral body replacement procedure, you will need to stay in the hospital for a few days. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About ATHLET®
ATHLET® is a vertebral body replacement implant for use in the spine. The implants serve as temporary placeholders to restore the spine until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in one footprint and variuos, heights to enable adaptation to different patient anatomies. The implant consists of a basic and end body, which are joined together using a click mechanism to ensure secure fixation. The surface has maximal cortical contact and therefore maximal stability of the implant.

ATHLET® Material
The implants are made from the following materials: Polyether ether ketone (PEEK-OPTIMA®) as per ASTM F2026
X-ray markers: Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment and enable interference-free X-ray imaging. An expert report recommends labelling ATHLET® as ‘MRI conditional’. A patient with this implant can be safely scanned in an MRI system in accordance with the justification and the test methods in ASTM F2502. Testing of the effects due to forces (ASTM F2052) or torque (ASTM F2213), heating (ASTM F2182) or artefact formation (ASTM F2119) was not carried out for the following reasons:
1. Long metallic objects less than 20 mm
2. Non-metallic PEEK as base material
3. Metal content less than 16 % proportional weight
4. Medical devices made of titanium and tantalum are labelled as ‘MRI conditional’ with < 25 T/m
5. The counterforces of the body hold the implant in position.

Undiserable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Pseudoarthrosis / absence of fusion
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Wear or breakage of implant components
• Pain or recurrent pain

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening arm or leg pain
• Any new or worsening weakness in your arms or legs
• Any new pins and needles or numbness in your arms or legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing neck pain
• Difficulties swallowing
• Problems with breathing

If you experience any serious incident in relation to ATHLET®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

NUBIC – Anterior Cervical Fusion

Download PDF version: NUBIC

Dear Patient,
Changes to the spine due to wear or disease are oftenaccompanied by pain that can greatly affect the quality of your life. In this brochure we would like to tell you about a the treatment for persistent symptoms in the neck (cervical spine).

Fusion of the Cervical Spine
Often these symptoms can be treated by conservative methods (medicines, physiotherapy, etc.). However, if the symptoms are not resolved or adequately eased, then an operation may become necessary. This surgery involves removing the disc bulge and any bony spurs in order to relieve the pressure on the compressed nerves and the spinal cord. To ensure lasting relief, this section of the spine may be stiffened (fused). Your surgeon may use autologous bone or special implants to achieve this. In some cases your surgeon might decide to also implant an additional fixating plate. This plate is placed in front of the cage and fixated in the adjacent vertebrae with two screws above and two screws underneath the treated disc.

The Operation with NUBIC®
Your surgeon gains access to the spine through a small incision in the front of your neck. The wound might be spread open using a retractor system. Next, the diseased disc and other compressing structures such as bony spurs are removed in order to relieve nerves and the spinal cord. Then, the NUBIC® implant is positioned into the available space and the wound is closed.

After the Operation
An operation on the cervical spine is generally not a major procedure and the NUBIC® implant is immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About NUBIC®
NUBIC® is a disc replacement implant for use in the cervical spine and is available as a high-performance medical polymer PEEK-OPTIMA®. It serves as temporary placeholder to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various footprints and heights to enable adaption to different patient anatomies. In some cases you surgeon might decide to fill the bone graft window with natural or synthetic bone graft substitute. For use with synthetic bone material, NUBIC® is available prefilled with KAINOS® +.

NUBIC® Material
The implants are made from the following materials:
Polyether ether ketone (PEEK-OPTIMA®) as per ASTM F2026
X-ray markers:
Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
For NUBIC® prefilled with KAINOS® +:
KAINOS® + consisting of hydroxylapatite as per ASTM F1185 and beta-tricalcium-phosphate as per ASTM F1088
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant, non-toxic in the biological environment and enable interference-free X-ray imaging.
The implant is conditionally MR safe. A patient with this implant can be safely scanned in an MRI system in accordance with the justification and the test methods in ASTM F2502. Testing of the effects due to forces, torque, heating or artefact formation was not carried out.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Pseudoarthrosis / absence of fusion
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Wear or breakage of implant components
• Pain or recurrent pain

If you experience any serious incident in relation to NUBIC®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

JASPIS ST – Anterior Cervical Fusion

Download PDF version: JASPIS ST

This brochure is intended to give you the important basic facts but it cannot replace individual advice from your doctor. Please ask your doctor for further questions in regard to your individual pathology indications. This and the implantation are the responsibility of the surgeon.

Fusion of the Cervical Spine
Often these symptoms can be treated by conservative methods (medicines, physiotherapy, etc.). However, if the symptoms are not resolved or adequately eased, then an operation may become necessary. This surgery involves removing the disc bulge and any bony spurs in order to relieve the pressure on the compressed nerves and the spinal cord. To ensure lasting relief, this section of the spine may be stiffened (fused). Your surgeon may use autologous bone or special implants to achieve this. In some cases your surgeon might decide to also implant an additonal fixating plate. This plate is placed in front of the cage and fixated in the adjecent vertebrae with two screws above and two screws underneath the treated disc.

The Operation with JASPIS® ST
Your surgeon gains access to the spine through a small incision in the front of your neck. The wound might be spread open using a retractor system. Next, the diseased disc and other compressing structures such as bony spurs are removed in order to relieve nerves and the spinal cord. Then, the JASPIS® ST implant is positioned into the available space and the wound is closed.

After the Operation
An operation on the cervical spine is generally not a major procedure and the JASPIS® ST implant is immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About JASPIS® ST
JASPIS® ST is a disc replacement implant for use in the cervical spine. It serves as a temporary placeholder to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies with / without lordosis (angles).

Material of JASPIS® ST
The implants are made from the following materials:
Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
The safety and compatibility of JASPIS® ST in an MRI environment was not determined. The product has not been tested with regard to heating, migration or artefact formation in an MRI environment.
Non-clinical testing has demonstrated the JASPIS® ST implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial field gradient of 11 T / m or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.7 W / kg for 15 minutes of scanning (i.e., per pulse sequence)
Under the scan conditions defined above, the JASPIS® ST implant is expected to produce a maximum temperature rise of less than 1.0°C after 15 minutes of continuous scanning. In non-clinical testing, the image artifact caused by the device extends approximately 25 mm from the JASPIS® ST implant when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Pseudoarthrosis / absence of fusion
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Wear or breakage of implant components
• Pain or recurrent pain
• Residual loose powder in the internal metal lattice

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening arm or leg pain
• Any new or worsening weakness in your arms or legs
• Any new pins and needles or numbness in your arms or legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing neck pain
• Difficulties swallowing
• Problems with breathing

If you experience any serious incident in relation to JASPIS® ST, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

Important information: Please keep in mind that SIGNUS Medizintechnik GmbH just provides general information about the treatment. Specific questions can only be answered by your doctor. SIGNUS assumes no liability for wrong indication or medical malpractice.

ASCOT – Anterior Cervical Stabilization

Download PDF version: ASCOT

Dear Patient,
Changes to the spine due to wear or disease of the disc as well as destructive damage of the vertebral body, such as that caused by tumours, fractures or inflammations are often accompanied by pain that can greatly affect the quality of your life. In this brochure we would like to tell you about a treatment for persistent symptoms in the neck (cervical spine).

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural ageing. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bony changes (e.g. bony spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighbouring nerves or the spinal cord which can cause severe pains that often radiate through the shoulder and arm, and disturbances of sensation (numbness, oversensitivity, etc.). Due to a fall or an accident or a bone density decreases with age (osteoporosis or thinning bones), the vertebrae and its structures can break. Bone fractures can heal again. Only if the fracture is unstable parts of the bone or bone splinters can jeopardise the spinal cord or the nerves. Another reason that may make surgical intervention necessary are spinal tumours which grow and multiply within or surrounding the spinal cord and / or spinal column. Spinal tumours can be beign (non-cancerous) or malignant (cancerous). Primary tumours originate in the spine or spinal cord, and metastatic or secondary tumours result from cancer spreading from another site to the spine.

Fusion of the Cervical Spine
If these symptoms cannot be neither treated by conservative methods nor resolved or adequately eased, then an operation may become necessary. Depending to the symptoms of your disease this may require a disc or vertebral body replacement. To ensure lasting relief, this section of the spine may be stiffened (fused). When replacing a vertebral body (please see SIGNUS patient leaflet for ATHLET®) there is always an additional fixation required. In case of removal of the intervertebral disc in the affected segment (please see SIGNUS patient leaflet JASPIS® ST, RABEA®, NUBIC®) your surgeon might decide to also implant an additional fixating plate. This additional fixating plate is placed in front of the implant and fixated in the adjacent vertebrae with two screws to achieve greater stability of the affected segment.

The Operation with ASCOT®
When removing the intervertebral disc or replacing the vertebral body your surgeon gains access to the spine through a small incision in the front of your neck. The wound might be spread open using a retractor system. Next, depending on your symptoms, either the diseased disc or the affected vertebral body will be removed. By using the same access the plate will be placed in front of the implant. With two screws above and two screws underneath the treated disc the plate is fixated in the adjacent vertebrae. Depending on the severity of the pathology to be treated, a one-level or multi-level fusion may be performed. New bone mass will gradually grow in and around the implant, creating a fusion which makes the area stable. This procedure will take away some flexibility in your spine, but most patients do not notice.

After the Operation
After a treatment at the cervical spine you will need to stay in the hospital for a few days. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About ASCOT®
ASCOT® is a complete screw-plate-system for stabilisation of the cervical spine. It serves to temporarily stabilise the spine until firm bony fusion has taken place. They are not explanted again but remain in the patient. The plates have a thickness of 1.8 mm, anatomic shape and are available in different lengths. The corresponding screws are also available in different lengths and diameters, to enable adaption to different patient anatomies.

ASCOT® Material
The implants are made from the following material:
Titanium alloy (Ti-6Al-4V ) as per ASTM F 136 / ISO 5832-3
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant, non-toxic in the biological environment. The implants are coated with oxide layers in different colours for easy identification. Colour changes are caused by factors related to production and reprocessing and do not affect the functionality.
Non-clinical trials demonstrated that the ASCOT® implants are ‘MRI conditional’. A patient with this implant can be safely examined in an MRI environment that complies with the following criteria:
• Static magnetic field strength of 1.5 T
• Maximum spatial magnetic field gradient of 700 Gauss / cm or less
• Maximum mean whole-body specific absorption rate (SAR) stated by the MRI system of 4 W / kg
Under these examination conditions a temperature increase in the implant of max 3.2° C (1.5 T) can be expected during a continuous examination over 15 minutes.
In non-clinical trials the image distortion caused by the product extended to about 15 mm around the ASCOT® implants when using a gradient echo sequence and a 3 T MRI system.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery. The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Postoperative loss of correction or changes in the spinal curvature
• Pseudoarthrosis / absence of fusion
• Pressure exerted on surrounding tissue by component parts in patients with inadequate tissue cover
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis Postoperative dysphagia with cervical plate systems
• Infection

If you experience any serious incident in relation to ASCOT®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

TOSCA – Anterior Cervical Stabilization

Download PDF version: TOSCA

Fusion of the Cervical Spine
If these symptoms cannot be neither treated by conservative methods nor resolved or adequately eased, then an operation may become necessary. Depending to the symptoms of your disease this may require a disc or vertebral body replacement. To ensure lasting relief, this section of the spine may be stiffened (fused). When replacing a vertebral body (please see SIGNUS patient leaflet for ATHLET®) there is always an additional fixation required. In case of removal of the intervertebral disc in the affected segment (please see SIGNUS patient leaflet JASPIS® ST, RABEA®, NUBIC®) your surgeon might decide to also implant an additional fixating plate This additional fixating plate is placed in front of the implant and fixated in the adjacent vertebrae with two screws to achieve greater stability of the affected segment.

The Operation with TOSCA®
When removing the intervertebral disc or replacing the vertebral body your surgeon gains access to the spine through a small incision in the front of your neck. The wound might be spread open using a retractor system. Next, depending on your symptoms, either the diseased disc or the affected vertebral body will be removed. By using the same access the plate will be placed in front of the implant. With two screws above and two screws underneath the treated disc the plate is fixated in the adjacent vertebrae. Depending on the severity of the pathology to be treated, a one-level or multi-level fusion may be performed. New bone mass will gradually grow in and around the implant, creating a fusion which makes the area stable. This procedure will take away some flexibility in your spine, but most patients do not notice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About TOSCA®
TOSCA® is a complete screw-plate-system for stabilisation of the cervical spine. It serves to temporarily stabilise the spine until firm bony fusion has taken place. They are not explanted again but remain in the patient. The plates have a thickness of 1.6 mm, anatomic shape and are available in different lengths. The corresponding screws are also available in different lengths and diameters, to enable adaption to different patient anatomies.

TOSCA® Material
The implants are made from the following material:
Titanium alloy (Ti-6Al-4V ) as per ASTM F 136 / ISO 5832-3
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant, non-toxic in the biological environment. The implants are coated with oxide layers in different colours for easy identification. Colour changes are caused by factors related to production and reprocessing and do not affect the functionality.
Non-clinical trials demonstrated that the TOSCA® implants are ‘MRI conditional’. A patient with this implant can be safely examined in an MRI environment that complies with the following criteria:
• Static magnetic field strength of 1.5 T
• Maximum spatial magnetic field gradient of 700 Gauss / cm or less
• Maximum mean whole-body specific absorption rate (SAR) stated by the MRI system of 4 W / kg
Under these examination conditions a temperature increase in the implant of max 3.2° C (1.5 T) can be expected during a continuous examination over 15 minutes.
In non-clinical trials the image distortion caused by the product extended to about 15 mm around the TOSCA® implants when using a gradient echo sequence and a 3 T MRI system.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery. The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Postoperative loss of correction or changes in the spinal curvature
• Pseudoarthrosis / absence of fusion
• Pressure exerted on surrounding tissue by component parts in patients with inadequate tissue cover
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis Postoperative dysphagia with cervical plate systems
• Infection

If you experience any serious incident in relation to TOSCA®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

VERTACONNECT – Transforaminal Lumbar Interbody Fusion

Download PDF version: VERTACONNECT

Dear Patient,
Changes to the spine due to wear or disease are often accompanied by pain that can greatly affect the quality of your life. In this brochure we would like to tell you about the treatment for persistent symptoms in the lower back (lumbar spine).

The Lumbar Spine
The spine is an extraordinarily complex system of bones, cartilage, muscles and nerves, that has both static and dynamic functions. In addition it protects the spinal cord that lies within it. The lumbar spine (low back) is the third major region of the spine. It is below the cervical and thoracic spine and consists of 5 small bones (L1 – L5), called the lumbar vertebrae. Each vertebra is stacked on top of the other and between each vertebra is a jelly-like cushion, called an intervertebral disc. The discs help to absorb pressure, distribute stress, and keep the vertebrae from grinding against each other.

The Operation with vertaconnect
During TLIF (Transforaminal Lumbar Interbody Fusion) a small incision is made in the back. The surgeon clears the path to the spine with special attention to nerves and vessels. VERTACONNECT is used as an expandable spacer between two vertebral bodies to restore the height, correct the spinal curvature and to relive impinched nerves. As the body heals, new bone grows around and through the VERTACONNECT to fuse the two vertebral bodies into one solid piece of bone. Depending on the symptoms, a one-level or multi-level fusion may be performed. Fusion will take away some flexibility in your spine, but most patients do not notice.

After the Operation
An operation on the lumbar spine is generally not a major procedure and the VERTACONNECT implant is – in combination with the additional fixation – immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About vertaconnect
VERTACONNECT is a disc replacement implant for use in the lumbar spine. It serves as a temporary placeholder to restore disc height until firm bony fusion has taken place. VERTACONNECT is not explanted again but remains in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies with / without lordosis (angles).

Material of vertaconnect
The implants are made from the following materials:
Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
The safety and compatibility of VERTACONNECT in an MRI environment was not determined. The product has not been tested with regard to heating, migration or artefact formation in an MRI environment.

If you experience any serious incident in relation to VERTACONNECT , please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

WOMBAT – Transforaminal Lumbar Interbody Fusion

Download PDF version: WOMBAT

This brochure is intended to give you the important basic facts but it cannot replace individual advice from your doctor. Please ask your doctor for further questions in regard to your individual pathology indications. This and the implantation are the responsibility of the surgeon.

Fusion of the Lumbar Spine
Often these symptoms can be treated by conservative methods (medicines, physiotherapy, etc.). However, if the symptoms are not resolved or adequately eased, then an operation may become necessary. This surgery involves removing the disc bulge and any bony spurs in order to relieve the pressure on the compressed nerves and the spinal cord. To ensure lasting relief, this section of the spine may be stiffened (fused). Your surgeon may use autologous bone or special implants to achieve this. For fusion of the lumbar spine there is always an additional
fixation required. Therefore your surgeon might decide to also implant fixating screws (pedicle screws) from the back. Depending on the surgeons´ choice of access, this screw-rod-system will be implanted in one step with the implant. If a second step is needed, your surgeon might either way decide to turn you around during the operation to place the screws or to do these two steps in two different surgeries (within approx. two weeks).

The Operation with WOMBAT®
During Transforaminal Lumbar Interbody Fusion (TLIF), an incision is made in your back. The surgeon clears the path to the spine, carefully moving aside the neural structures, and removes the damaged disc. WOMBAT® is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. As the body heals, new bone grows around and through the WOMBAT® spacer to fuse the two vertebrae into one solid piece of bone. Depending on the symptoms, a one-level or multi-level fusion may be performed. Fusion will take away some flexibility in your spine, but most patients do not notice.

After the Operation
An operation on the lumbar spine is generally not a major procedure and the WOMBAT® implant is – in combination with the additional fixation – immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About WOMBAT®
WOMBAT® is a spinal fusion implant for use in the lumbar spine. The implants serve as temporary placeholders to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies.

Material of WOMBAT®
The implants and X-ray markers described are made from the following materials:
• PEEK-OPTIMA as per ASTM F2026
• Titanium alloy (Ti-6Al-4V) as per ASTM F136 / ISO 5832-3
• Tantalum as per ASTM F560
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
Non-clinical testing has demonstrated the WOMBAT® ST implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T and 3.0 T, only
• Maximum spatial field gradient of 12000 gauss / cm (extrapolated) or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W / kg for 15 minutes of scanning (i.e., per pulse sequence)
Under the scan conditions defined above, the WOMBAT® ST implant is expected to produce a maximum temperature rise of less than 2.1º C (for 1.5 T MRI) and 2.5º C (for 3.0 T MRI) after 15 minutes of continuous scanning.
In non-clinical testing, the image artefact caused by the device extends approximately 10 mm from the WOMBAT® ST implant when imaged with a gradient echo pulse sequence and a 1.5 T MRI system.
An expert report recommends labelling WOMBAT® PEEK as ‘MR conditional’. A patient with this implant can be safely scanned in an MRI system in accordance with the justification and the test methods in ASTM F2502.
Testing of the effects due to forces (ASTM F2052) or torque (ASTM F2213), heating (ASTM F2182) or artefact formation (ASTM F2119) was not carried out for the following reasons:
1. Long metallic objects less than 20 mm
2. Non-metallic PEEK as base material
3. Metal content less than 16 % proportional weight
4. Medical devices made of titanium and tantalum are labelled as ‘MR conditional’ with < 25 T/m
5. The counterforces of the body hold the implant in position.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Wear or breakage of implant components
• Loss of ﬁxation, dislocation, subsidence
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Infection
• Vascular lesion
• Neural lesions with reversible or permanent neurological deﬁcits or paralysis

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing back pain
• Difficulties of breathing
• General malais

If you experience any serious incident in relation to WOMBAT®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

MOBIS / MOBIS II – Transforaminal Lumbar Interbody Fusion

Download PDF version: MOBIS / MOBIS II

Fusion of the Lumbar Spine
Often these symptoms can be treated by conservative methods (medicines, physiotherapy, etc.). However, if the symptoms are not resolved or adequately eased, then an operation may become necessary. This surgery involves removing the disc bulge and any bony spurs in order to relieve the pressure on the compressed nerves and the spinal cord. To ensure lasting relief, this section of the spine may be stiffened (fused). Your surgeon may use autologous bone or special implants to achieve this. For fusion of the lumbar spine there is always an additional
fixation required. Therefore your surgeon might decide to also implant fixating screws (pedicle screws) from the back. Depending on the surgeons´ choice of access, this screw-rod-system will be implanted in one step with the implant. If a second step is needed, your surgeon might either way decide to turn you around during the operation to place the screws or to do these two steps in two different surgeries (within approx. two weeks).

The Operation with MOBIS®/ MOBIS® II
During Transforaminal Lumbar Interbody Fusion (TLIF), an incision is made in your back. The surgeon clears the path to the spine, carefully moving aside the neural structures, and removes the damaged disc. MOBIS®/ MOBIS® II is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. As the body heals, new bone grows around and through the MOBIS®/ MOBIS® II spacer to fuse the two vertebrae into one solid piece of bone. Depending on the symptoms, a one-level or multi-level fusion may be performed. Fusion will take away some flexibility in your spine, but most patients do not notice.

After the Operation
An operation on the lumbar spine is generally not a major procedure and the MOBIS®/ MOBIS® II implant is – in combination with the additional fixation – immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About MOBIS®/ MOBIS® II
MOBIS®/ MOBIS® II is a spinal fusion implant for use in the lumbar spine. The implants serve as temporary placeholders to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies.

Material of MOBIS®/ MOBIS® II
The implants and X-ray markers described are made from the following materials:
• PEEK-OPTIMA® as per ASTM F2026
• Titanium alloy (Ti-6Al-4V) as per ASTM F136 / ISO 5832-3
• Titanium as per ASTM F67 / ISO 5832-2
• Tantalum as per ASTM F560
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
Non-clinical testing has demonstrated the MOBIS® II ST implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T, only
• Maximum spatial field gradient of 1,200 gauss / cm or less
• Maximum MRI system reported, whole body averaged specific absorption rate (SAR) of 4-W / kg for 15 minutes of scanning (i.e., per pulse sequence)
Under the scan conditions defined above, the MOBIS® II ST implant is expected to produce a maximum temperature rise of less than 2.5º C after 15 minutes of continuous scanning.
In non-clinical testing, the image artefact caused by the device extends approximately 10 mm from the MOBIS® II ST implant when imaged with a gradient echo pulse sequence and a 1.5 T MRI system.
An expert report recommends labelling MOBIS® / MOBIS® II PEEK as ‘MR conditional’. A patient with this implant can be safely scanned in an MRI system in accordance with the justification and the test methods in ASTM F2502.
Testing of the effects due to forces (ASTM F2052) or torque (ASTM F2213), heating (ASTM F2182) or artefact formation (ASTM F2119) was not carried out for the following reasons:
1. Long metallic objects less than 20 mm
2. Non-metallic PEEK as base material
3. Metal content less than 16 % proportional weight
4. Medical devices made of titanium and tantalum are labelled as ‘MR conditional’ with < 25 T/m
5. The counterforces of the body hold the implant in position.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Wear or breakage of implant components
• Loss of ﬁxation, dislocation, subsidence
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Infection
• Vascular lesion
• Neural lesions with reversible or permanent neurological deﬁcits or paralysis

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing back pain
• Difficulties of breathing
• General malais

If you experience any serious incident in relation to MOBIS®/ MOBIS® II, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

TASMIN R – Posterior Lumbar Interbody Fusion

Download PDF version: TASMIN R

The Operation with TASMIN® R
During Posterior Lumbar Interbody Fusion (PLIF), an incision is made in your back. The surgeon clears the path to the spine, carefully moving aside the neural structures, and removes the damaged disc. TASMIN® R is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. As the body heals, new bone grows around and through the TASMIN® R spacer to fuse the two vertebrae into one solid piece of bone. Depending on the symptoms, a one-level or multi-level fusion may be performed. Fusion will take away some flexibility in your spine, but most patients do not notice.

After the Operation
An operation on the lumbar spine is generally not a major procedure and the TASMIN® R implant is – in combination with the additional fixation – immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About TASMIN® R
TASMIN® R is a spinal fusion implant for use in the lumbar spine. The implants serve as temporary placeholders to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies.

Material of TASMIN® R
The implants and X-ray markers described are made from the following materials:
• PEEK-OPTIMA® as per ASTM F2026
• Tantalum as per ASTM F560
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
An expert report recommends labelling TASMIN® R as ‘MR conditional’. A patient with this implant can be safely scanned in an MRI system in accordance with the justification and the test methods in ASTM F2502.
Testing of the effects due to forces (ASTM F2052) or torque (ASTM F2213), heating (ASTM F2182) or artefact formation (ASTM F2119) was not carried out for the following reasons:
1. Long metallic objects less than 20 mm
2. Non-metallic PEEK as base material
3. Metal content less than 16 % proportional weight
4. Medical devices made of titanium and tantalum are labelled as ‘MR conditional’ with < 25 T/m
5. The counterforces of the body hold the implant in position.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Wear or breakage of implant components
• Loss of ﬁxation, dislocation, subsidence
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Infection
• Vascular lesion
• Neural lesions with reversible or permanent neurological deﬁcits or paralysis

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing back pain
• Difficulties of breathing
• General malais

If you experience any serious incident in relation to TASMIN® R, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

TETRIS / TETRIS II – Posterior Lumbar Interbody Fusion

Download PDF version: TETRIS / TETRIS II

The Operation with TETRIS™/ TETRIS™ II
During Posterior Lumbar Interbody Fusion (PLIF), an incision is made in your back. The surgeon clears the path to the spine, carefully moving aside the neural structures, and removes the damaged disc. TETRIS™/ TETRIS™ II is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. As the body heals, new bone grows around and through the TETRIS™/ TETRIS™ II spacer to fuse the two vertebrae into one solid piece of bone. Depending on the symptoms, a one-level or multi-level fusion may be performed. Fusion will take away some flexibility in your spine, but most patients do not notice.

After the Operation
An operation on the lumbar spine is generally not a major procedure and the TETRIS™/ TETRIS™ II implant is – in combination with the additional fixation – immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About TETRIS™/ TETRIS™ II
TETRIS™/ TETRIS™ II is a spinal fusion implant for use in the lumbar spine. The implants serve as temporary placeholders to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies.

Material of TETRIS™/ TETRIS™ II
The implants and X-ray markers described are made from the following materials:
• PEEK-OPTIMA® as per ASTM F2026
• Titanium alloy (Ti-6Al-4V) as per ASTM F136 / ISO 5832-3
• Titanium as per ASTM F67 / ISO 5832-2
• Tantalum as per ASTM F560
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
Non-clinical testing has demonstrated the TETRIS™ Titanium implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial field gradient of 720 gauss / cm or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.9 W / kg for 15 minutes of scanning (i.e., per pulse sequence)
Under the scan conditions defined above, the TETRIS™ Titanium implant is expected to produce a maximum temperature rise of less than 1.8º C (for 1.5 T MRI) and 2.1º C (for 3.0 T MRI) after 15 minutes of continuous scanning.
In non-clinical testing, the image artefact caused by the device extends approximately 15 mm from the TETRIS™ Titanium implant when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.
An expert report recommends labelling TETRIS™ II PEEK as ‘MR conditional’. A patient with this implant can be safely scanned in an MRI system in accordance with the justification and the test methods in ASTM F2502.
Testing of the effects due to forces (ASTM F2052) or torque (ASTM F2213), heating (ASTM F2182) or artefact formation (ASTM F2119) was not carried out for the following reasons:
1. Long metallic objects less than 20 mm
2. Non-metallic PEEK as base material
3. Metal content less than 16 % proportional weight
4. Medical devices made of titanium and tantalum are labelled as ‘MR conditional’ with < 25 T/m
5. The counterforces of the body hold the implant in position.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Wear or breakage of implant components
• Loss of ﬁxation, dislocation, subsidence
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Infection
• Vascular lesion
• Neural lesions with reversible or permanent neurological deﬁcits or paralysis

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing back pain
• Difficulties of breathing
• General malais

If you experience any serious incident in relation to TETRIS™/ TETRIS™ II, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

BIG ST – Anterior Lumbar Interbody Fusion

Download PDF version: BIG ST

Fusion of the Lumbar Spine
Often these symptoms can be treated by conservative methods (medicines, physiotherapy, etc.). However, if the symptoms are not resolved or adequately eased, then an operation may become necessary. This surgery involves removing the disc bulge and any bony spurs in order to relieve the pressure on the compressed nerves and the spinal cord. To ensure lasting relief, this section of the spine may be stiffened (fused). Your surgeon may use autologous bone or special implants to achieve this. For fusion of the lumbar spine there is always an additional
fixation required. With BIG® ST this can be done by using the BIG® ST fixation screws, which are placed through the cage, using the same approach as for inserting the BIG® ST implant (stand alone procedure). In some cases your surgeon might decide to also implant additional fixating screws from the back. Your surgeon might either way decide to turn you around during the operation to place the screws or to do these two steps in two different surgeries (within approx. two weeks). It is also possible to insert the BIG® ST without using the fixation screws through the cage, but implanting a screw system from the back instead as additional fixation.

The Operation with BIG® ST
During Anterior Lumbar Interbody Fusion (ALIF), an incision is made in the front of the belly. The surgeon clears the path to the spine, moving aside the vessels to the legs, and removes the damaged disc. BIG® ST is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. As the body heals, new bone grows around and through the BIG® ST spacer to fuse the two vertebrae into one solid piece of bone. Depending on the symptoms, a one-level or multi-level fusion may be performed. Fusion will take away some flexibility in your spine, but most patients do not notice.

After the Operation
An operation on the lumbar spine is generally not a major procedure and the BIG® ST implant is – in combination with the additional fixation – immediately stable, so you can get out of bed on the day of the operation if you are feeling well. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About BIG® ST
BIG® ST is a spinal fusion implant for use in the lumbar spine. The implants serve as temporary placeholders to restore disc height until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints and heights to enable adaptation to different patient anatomies. Also the BIG® ST fixation screws are available in different lengths.

Material of BIG® ST
The implants are made from the following materials:
Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
Non-clinical trials demonstrated that the BIG® ST implant is ‘MRI conditional’. A patient with this implant can be safely examined in an MRI environment that complies with the following criteria:
• Static magnetic field strength of 1.5 T
• Maximum spatial magnetic field gradient of 700 Gauss / cm or less
• Maximum mean whole-body specific absorption rate (SAR) stated by the MRI system of 4 W / kg
Under these examination conditions a temperature increase in the implant of max 2.3° C (1.5 T) can be expected during a continuous examination over 15 minutes.
In non-clinical trials the image distortion caused by the product extended to about 15 mm around the BIG® ST implant when using a gradient echo sequence and a 3 T MRI system.

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing lower back pain
• Difficulties of breathing
• General malais

If you experience any serious incident in relation to BIG® ST, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

DIPLOMAT – Posterior Instrumentation

Download PDF version: DIPLOMAT

Dear Patient,
Changes in the spine due to wear and tear or disease are often accompanied by pain and can severely impair your quality of life. This brochure provides you with information on “stiffening” (fusion) of the spine. It is of a general nature and does not constitute medical advice or a medical recommendation. The information does not make any diagnostic or therapeutic statement about the respective individual medical case.

The Spine
The spine is an extraordinarily complex system of bones, cartilage, muscles, ligaments and nerves that combines both static and dynamic functions. It also protects the spinal cord that lies within it. The spine is divided into the cervical (Cervical, C1 – C7), thoracic (Thoracic, TH1 – TH12) and lumbar (Lumbar L1 – L5) regions. Adjacent to the lumbar is the sacrum. The sacrum is an ossification of four to five vertebrae fused together to form a unified bone. Between the individual vertebrae sit the intervertebral discs. Together with the ilium, the coccyx forms the sacroiliac joint (SIG). This provides the connection of the spine to the pelvis. If you look at the spine from the side, you can see a double-S-shaped curvature, which serves to protect against shocks and to best cope with the stresses and demands of everyday life. This curvature is created by the different bending of each spinal segment. The cervical and lumbar spine is curve forward, which is called lordosis. The thoracic spine and sacrum, on the other hand, curve backward and are termed kyphosis.

Fusion of the Lumbar Spine
If symptoms cannot be eliminated or sufficiently alleviated by conservative therapy or appropriate pain medication, surgery may be necessary. Depending on your personal clinical picture, this may require a rod-screw system, whereby the diseased part of the spine is stiffened (fused). This could be for example, in the case of massive constriction of the nerves or spinal cord (spinal canal stenosis), in order to prevent permanent damage, or in the case of instabilities such as spondylolisthesis. The goal is always to ensure a long-term improvement in your symptoms. In the case of a treatment using a rod-screw system, an additional insertion of a cage (shaped placeholder) is often required (see also SIGNUS patient information MOBIS®, WOMBAT®).

The Operation with DIPLOMAT®
The operation is usually performed in the prone position on special positioning pillows. Through a skin incision on the back, the muscles are pushed aside and the spine is exposed. DIPLOMAT® screws are then inserted into the vertebral bodies and attached with connecting rods. Often it is as well necessary to remove excess bone tissue or disc material, which presses on the sensitive nerves and thus causes the pain. Together with the screws, after removal of the intervertebral disc, a shaped placeholder (cage) is usually also inserted into the intervertebral space. It restores the physiological (natural) height of the disc segment. The screws and rods ensure the stability of the spine and guarantee immobilization until the bone, with or without the cage, has fused (stiffened) the vertebral bodies .

After the Operation
After lumbar spine surgery, you will need to stay in the hospital for a few days. Nevertheless, aftercare and follow-up examinations will be tailored to your individual needs by your attending surgeon. After surgical treatment, you will be allowed limited physical activity for a period of time. This includes lifting heavy objects, rotational movements and any type of sports. Falls and jerky movements should be avoided at all costs. Your surgeon will give you more information about the above measures and will create an individualized aftercare plan with you (physiotherapy, mobilization, strength exercises) so that you can quickly return to everyday life. Your surgeon will also suggest further aftercare if necessary. Please always follow the doctor’s advice.

Identification of the Implant
Information identifying your implant, as well as the SIGNUS name, address and website can be found on your implantation card, which will be given to you by your treating physician.

About DIPLOMAT®
The DIPLOMAT® system is a well thought-out modular and proven screw-rod-system for stabilization of the spine. It was developed in close collaboration with experienced qualified spine surgeons. The cannulated and fenestrated DIPLOMAT® screws in combination with 5.5 mm titanium rods allow the system to stabilize and comfortably correct all types of spinal disorders and deformities in a controlled manner. The screws are available in different diameters and lengths, the rods in different lengths. This enables adaptation to different patient anatomies.

DIPLOMAT® Material
The implants are made of the following materials:
• Titanium alloy (Ti-6Al-4V) according to ASTM F 136 / ISO 5832-3
• Cobalt-chromium-molybdenum alloy according to ASTM F 1537 / ISO 5832-12
These materials are established for implant use. They are biocompatible, corrosion resistant and non-toxic in the biological environment. For easy identification, the implants are coated with oxide layers of different colours. Colour changes are due to production and processing and do not affect functionality. The safety and compatibility of DIPLOMAT® in an MRI environment has not been determined. The products have not been tested for heating, migration or artefact formation in an MRI environment.

Undesirable Side Effects
Your doctor will inform you of the general risks and possible complications of the surgery.
The following are possible risks and complications associated with the implant that may require revision surgery:
• Pseudoarthrosis / failure to fuse.
• Foreign body sensitivity, allergic or other local / systemic side effects regarding the implant materials used
• Misplacement
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Pedicle fracture
• Pedicle / nerve root perforation
• Nerve root / spinal canal injury
• Injury and vascular damage due to bone cement leakage (e.g., PMMA)
• Visceral injury / infection and deep wound infection
• Temporary para paresis
• Wear, bending or fracture of implant components
• Screw loosening
• Pain or recurrent pain

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Progressive leg pain
• New or progressive tingling, pain, or weakness in your legs / feet
• New symptoms of paralysis
• Incontinence (bladder or rectum)
• Fever or elevated temperature
• Redness, swelling, or discharge from the wound

If you experience any serious incident in relation to DIPLOMAT®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

DIPLOMAT Deformity – Treatment Of Spinal Deformities

Download PDF version: DIPLOMAT Deformity

Fusion of the Lumbar Spine
If symptoms cannot be eliminated or sufficiently alleviated by conservative therapy or appropriate pain medication, surgery may be necessary. Depending on your personal medical condition, a hook-based system (possibly in combination with a rodscrew-system) may be necessary, whereby the pathological part of the spine is stiffened (fused). For example, increasing instability of the motion segments can cause slippage and twisting of the spine (deformity). The aim is to always ensure a lasting improvement of your symptoms. For a treatment using a rod-screw system, an additional cage (shaped placeholder) is often required (see also SIGNUS Patient Information MOBIS®, WOMBAT®).

The Operation with DIPLOMAT® Deformity
The operation is usually performed in the prone position on special positioning pillows. Through a skin incision on the back, the muscles are pushed aside, the spine is exposed and the spinal deformity is eliminated. For this purpose, DIPLOMAT® Deformity hooks are inserted at the lamina and connected with connecting rods (bars). Often in connection with DIPLOMAT® screws which are placed in the vertebral body. Regularly it is also necessary to remove excess bone tissue or disc material, which presses on the sensitive nerves and thus causes the pain. Additional support is then provided by a placeholder (cage), which is inserted into the intervertebral space. It restores the physiological (natural) height of the disc segment. The hooks, screws and rods contribute to the stability of the spine and ensure immobilization until the bone has fused (stiffened) with or without the cage.

After the Operation
After lumbar spine surgery, you will need to stay in the hospital for a few days. Nevertheless, aftercare and follow-up examinations will be tailored to your individual needs by your attending surgeon. After surgical treatment, you will be allowed limited physical activity for a period of time. This includes lifting heavy objects, rotational movements and any type of sports. Falls and jerky movements should be avoided at all costs.Your surgeon will give you more information about the above measures and will create an individualized aftercare plan with you (physiotherapy, mobilization, strength exercises) so that you can quickly return to everyday life. Your surgeon will also suggest further aftercare if necessary. Please always follow the doctor’s advice.

Identification of the Implant
Information identifying your implant, as well as the SIGNUS name, address and website can be found on your implantation card, which will be given to you by your treating physician.

About DIPLOMAT® Deformity
The DIPLOMAT® Deformity system is a sophisticated hook-rod-system for stabilizing the spine. It was developed in close cooperation with experienced qualified spine surgeons. The DIPLOMAT® Deformity hooks (with screws if necessary) in combination with 5.5 mm titanium rods allow the system to stabilize all types of spinal disorders and deformities in a controlled manner and to correct them comfortably. The hooks and screws are available in different diameters and lengths, the rods in different lengths. This allows for adaptation to different patient anatomies.

DIPLOMAT® Deformity Material
The implants are made of the following materials:
• Titanium alloy (Ti-6Al-4V) according to ASTM F 136 / ISO 5832-3
• Cobalt-chromium-molybdenum alloy according to ASTM F 1537 / ISO 5832-12
These materials are established for implant use. They are biocompatible, corrosion resistant and non-toxic in the biological environment.
For easy identification, the implants are coated with oxide layers of different colours. Colour changes are due to production and processing and do not affect functionality.
The safety and compatibility of DIPLOMAT® Deformity in an MRI environment has not been determined. The products have not been tested for heating, migration or artefact formation in an MRI environment.

Undesirable Side Effects
Your doctor will inform you of the general risks and possible complications of the surgery.
The following are possible risks and complications associated with the implant that may require revision surgery:
• Pseudoarthrosis / failure to fuse.
• Foreign body sensitivity, allergic or other local / systemic side effects regarding the implant materials used
• Misplacement
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Pedicle fracture
• Pedicle / nerve root perforation
• Nerve root / spinal canal injury
• Injury and vascular damage due to bone cement leakage (e.g., PMMA)
• Visceral injury / infection and deep wound infection
• Temporary para paresis
• Wear, bending or fracture of implant components
• Screw loosening
• Pain or recurrent pain

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Progressive leg pain
• New or progressive tingling, pain, or weakness in your legs / feet
• New symptoms of paralysis
• Incontinence (bladder or rectum)
• Fever or elevated temperature
• Redness, swelling, or discharge from

If you experience any serious incident in relation to DIPLOMAT® Deformity, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

POSEIDON – Expandable Vertebral Body Replacement

Download PDF version: POSEIDON

Dear Patient,
Destructive damage of the vertebral body, such as that caused by tumors, fractures or inflammations, can greatly affect the quality of your life. In this brochure we would like to tell you about the treatment of these damages in the thoracic and lumbar regions of the spine.

The Thoracolumbar Spine
The spine is an extraordinarily complex system of bones, cartilage, muscles and nerves, that has both static and dynamic functions. In addition it protects the spinal cord that lies within it. The thoracic spine is the second segment of the vertebral column, located between the cervical and lumbar vertebral segments. It consists of 12 small bones (TH1 – TH12), called the thoracic vertebrae. The lumbar spine (low back) is the third major region of the spine. It is below the cervical and thoracic spine and consists of 5 small bones (L1 – L5), called the lumbar vertebrae. Each vertebra is stacked on top of the other and between each vertebra is a jelly-like cushion, called an intervertebral disc. The discs help to absorb pressure, distribute stress, and keep the vertebrae from grinding against each other.

Destructive Damage of the Thoracolumbar Spine
The individual vertebrae in the spinal column are made up of the vertebral body, the spinous process and the vertebral arch. Like all other bones in the body, these structures can also break (fracture) – whether due to a fall, an accident or a bone density decreases with age (osteoporosis or thinning bones). Bone fractures can heal again. Only if the fracture is unstable, parts of the bone or bone splinters can jeopardise the spinal cord or the nerves. A spinal tumor is an abnormal mass of tissue within or surrounding the spinal cord and / or spinal column. These cells grow and multiply uncontrollagly, semmingly unchecked by the machanisms that control normal cells. Spinal tumors can be beign (non-cancerous) or malignant (cancerous). Primary tumors originate in the spine or spinal cord, and metastatic or secondary tumors result from cancer spreading from another site to the spine. The bony spinal column is the most common site for bone metastasis. The most common primary spine tumor (originated in the bony spine) is vertebral hemangiomas. These are benign lesions and rarely cause symptoms such as pain. Inflammatory disorders of the spine can be caused by a wide range of conditions, including arthritis, osteoporosis, and infection. Inflammation in the spine is rare but can be a significant source of pain and disability, especially if these hard-to-diagnose conditions go untreated. Ankylosing spondylitis, a form of arthritis in the spine, is one of the most common spinal inflammatory disorders.

This brochure is intended to give you the important basic facts but it cannot replace individual advice from your doctor. Please ask your doctor for further questions in regard to your individual pathology indications. This and the implantation are the responsibility of the surgeon.

Replacement of a Vertebral Body
If these symptoms cannot be resolved or adequately eased, then an operation may become necessary. In this case, the related verebrae has to be removed and replaced by an implant so that the stability of the spine can be maintained. So that these implants are stably anchored, the top and bottom of the implant are placed directly on the neighbouring vertebral bodies and not the discs. Therefore adjacent discs are also removed, before placing the implant. When replacing a vertebral body there is always an additional fixation required. Therefore your surgeon might decide to also implant fixating screws (pedicle screws) from the back. Depending on the surgeons´ choice of access, this screw-rod-system will be implanted in one step with the implant. If a second step is needed, your surgeon might either way decide to turn you around during the operation to place the screws or to do these two steps in two different surgeries (within approx. two weeks).

The Operation with POSEIDON®
Before placing the implant your surgeon will decide which access is best for you. This decision is made respecting indication (level of the spine that has to be treated) and your individual anatomy. After the incision is made the surgeon clears the path to the spine and to the related vertebrae. The damaged vertebrae as well as adjacent discs will be removed. POSEIDON® is used as a spacer between the bones to restore the height, correct the spinal curvature, and to relieve pinched nerves. In a next step the screw-rod-system is placed to increase stability. Depending on the symptoms and the damaged vertebrae, a one-level or multi-level fusion may be performed. New bone mass will gradually grow in and around the implant, creating a fusion which makes the area stable. This procedure will take away some flexibility in your spine, but most patients do not notice.

After the Operation
After the vertebral body replacement procedure, you will need to stay in the hospital for a few days. Nevertheless aftercare and follow-up examinations are determined by your treating physician to your individual requirements. After the intervention, you will be allowed only very limited physical activity for an appropriate postoperative period. This applies in particular to the lifting of loads, rotating movements and any type of sport. Falls and sudden, jerky movements of the operated region must be avoided. Your surgeon will give you more detailed information about what you can do after the operation and will also provide an individual plan for your aftercare (physiotherapy, mobilisation, muscle strengthening, etc.), so that you can quickly get back into your daily routine. Your doctor will also inform you if further follow-up examinations are necessary. Please follow your doctor´s advice.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

About POSEIDON®
POSEIDON® is a vertebral body replacement implant for use in the spine. The implants serve as temporary placeholders to restore the spine until firm bony fusion has taken place. They are not explanted again but remain in the patient. The implants are available in various designs, footprints, heights and angles to enable adaptation to different patient anatomies. The implant consists of one main body, which is expandable within the patient to obtain the needed height accoring to the patients´ anatomy. Various endplates of different footprints and angles are mounted on both sides of the main body for maximal cortical contact and therefore maximum stability of the implant.

Material of POSEIDON®
The implants are made from the following materials:
• Titanium alloy (TiAl6V4) as per ASTM F 136 / ISO 5832-3
• Titanium as per ASTM F67 / ISO 5832-2
The materials are established materials for use as an implant. They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
Non-clinical trials demonstrated that the POSEIDON® ST implant is ‘MRI conditional’.
A patient with this implant can be safely examined in an MRI environment that complies with the following criteria:
• Static magnetic field strength of 1.5 T or 3 T
• Maximum spatial magnetic field gradient of 11 T/m (1.5 T) or 7 T/m (3 T) or less
• Maximum mean whole-body specific absorption rate (SAR) stated by the MRI system of 4.5 W/kg
Under these examination conditions a temperature increase in the implant of max 7.7°C (1.5 T) can be expected during a continuous examination over 15 minutes.
In non-clinical trials the image distortion caused by the product extended to about 3.5 cm around the POSEIDON® ST implant when using a gradient echo sequence and a 3 T MRI system.

The safety and compatibility of POSEIDON® in an MRI environment was not determined. The product has not been tested with regard to heating, migration or artefact formation in an MRI
environment.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Pseudoarthrosis / absence of fusion
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Vascular lesion
• Neural lesions with reversible or permanent neurological deficits or paralysis
• Infection
• Wear or breakage of implant components
• Pain or recurrent pain
• Residual loose powder in the internal metal lattice

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing back pain
• Difficulties of breathing
• General malaise

If you experience any serious incident in relation to POSEIDON®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

Important information: Please keep in mind that SIGNUS Medizintechnik GmbH just provides general information about the treatment. Specific questions can only be answered by your doctor. SIGNUS assumes no liability for wrong indication or medical malpractice.

DIANA – Sacroiliac Fusion System

Download PDF version: DIANA

Dear patient,
pain in the sacroiliac joint is called sacroiliac joint dysfunction, sacroiliac joint syndrome or sacroiliac joint arthropathy. This brochure is intended to provide you with a brief overview of its background and the treatment options for this illness.

What is the Sacroiliac Joint?
The sacroiliac joints (SIJ) are weight-bearing joints that are situated between the hip joints and the spine. The sacroiliac joint is a true joint that can be exposed to the same wear and tear as other joints. Although the joint only has a small range of movement (up to 3°), it plays an important role in almost every physical activity in everyday life.

What causes Sacroiliac Joint Pain?
For many years it has been known that the sacroiliac joint can cause severe pain that is associated with considerable reduction in the quality of life. The nature of the pain is comparable to that of other pain that arises in the region of the lower lumbar spine. Besides normal wear and tear, a disorder of the joint can result from preceding surgery to the lumbar spine, long-term sequels of a pelvic fracture, pregnancy, a fall, or inflammation.

How can a SIJ Syndrome be diagnosed?
A sacroiliac syndrome can only be clearly diagnosed on the basis of a combination of numerous individual examinations. Thus, for instance, radiological imaging (X-ray, MRI, CT) of the SIJ often yields largely inconspicuous findings, and these examinations are therefore not sufficient in themselves. A clarifying anesthetization of the joint by a specialist can in some cases confirm an SIJ syndrome. The medical history and physical examination by the doctor provide decisive indications. All the results of these examinations must be interpreted carefully and must be in line with each other when considered as a whole in order to rule out other causes of pain.

When is a DIANA® Operation recommended?
This surgical intervention is recommended in cases where the possibilities offered by all the aforementioned therapies have been exhausted and when symptom-free intervals become shorter over time. Also, there must be no general medical reasons for refraining from surgery.

How is the Operation carried out?
The DIANA® implant is inserted through a small incision (approx 5 cm) bringing the ligaments and the articular surfaces of the sacroiliac joint to the normal state. This process is called »ligamentotaxis «. At the same time, bone material or bone replacement material is added to ensure stable, permanent immobilization of the joint after completion of the healing phase.

About DIANA®
DIANA® provides a simple and safe treatment technique for the sacroiliac joint. In a gentle and low-risk procedure, the DIANA® method (Distraction-Interference-Arthrodesis sparing Neurovascular (nerve and blood vessel related) Aspects) anchors an interference implant via a posterior access distally in the iliac bone. The proximal and central implant area is located in the extra-articular recess without affecting the actual articular surfaces.

Important Information for after the Operation
Be patient! Avoid falling! Follow your surgeon’s instructions for ‘tip toe’ weight-bearing to a maximum of 20 kg for 8 weeks! Increase weight-bearing gradually! Avoid sexual activities during the partial weight-bearing period! Don’t engage in any sports for a period of 6 months after the surgery! You should only have physical therapy after bone healing has been confirmed!

Experience with the Operation
Clinical experience since this surgical technique was first used (2010) show a clear improvement in the quality of life and a reduction in the SIJ pain culminating in complete freedom from pain.
The long-term use of pain medication is reduced culminating in cessation of pain medication altogether.

Implant Identification
You will find information to identify your implant as well as the name, address and website of SIGNUS on your implantation card, which will be given to you by your surgeon.

Material of DIANA®
The implants described are made from the following materials:
• Titanium alloy (Ti-6Al-4V) as per ASTM F136 / ISO 5832-3
The materials are established materials for use as an implant.
They are biocompatible, corrosion-resistant and non-toxic in the biological environment.
The safety and compatibility of DIANA® in an MRI environment was not determined. The product has not been tested with regard to heating, migration or artefact formation in an MRI environment.

Undesirable Side Effects
Your doctor will inform you about general risks and possible complications of the spinal surgery.
The following are potential risks and complications related to the implant and which may necessitate repeat surgery:
• Loss of anchorage / fixation, subsidence or dislocation of the implant
• Sensitivity to foreign bodies, allergic reactions or other local / systemic adverse reactions to the implant materials used
• Incorrect placement
• Infection
• Wear or breakage of implant components
• Pain or recurrent pain
• Residual loose powder in the internal metal lattice
• Absence of fusion

When you should consult a Health Professional
If you experience one or more of the following, we recommend to contact your physician or any health professional:
• Worsening leg pain
• Any new or worsening weakness in your legs
• Any new pins and needles or numbness in your legs
• Incontinence (bladder or bowel)
• A fever or a high temperature
• Redness, swelling or discharge from the wound
• Increasing back pain
• General malais

If you experience any serious incident in relation to DIANA®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).
If you are resident in Australia, please also report to the Therapeutic Goods Administration (https://www.tga.gov.au/reporting-problems).

Important information: Please keep in mind that SIGNUS Medizintechnik GmbH just provides general information about the treatment. Specific questions can only be answered by your doctor. SIGNUS assumes no liability for wrong indication or medical malpractice.

Introduction

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