Introduction

Download PDF version: RABEA

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 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 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.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring 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.).

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 bone 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 RABEA®
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 bone spurs are removed in order to relieve nerves and the spinal cord. Then, the RABEA® 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 RABEA® 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, mobilization, 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 RABEA®
RABEA® is a disc replacement implant for use in the cervical spine and is available as a high-performance medical polymer PEEK-OPTIMA® or titanium. It serves as temporary placeholder to restore disc height until firm bone 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 adaption to different patient anatomies.

RABEA® Material
The implants are made from the following materials:
Polyether ether ketone (PEEK-OPTIMA®) as per ASTM F2026
Or
Titanium alloy (Ti-6Al-4V) as per ASTM F 136 / ISO 5832-3
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, non-toxic in the biological environment. Implants made of PEEK enable interference-free X-ray imaging.

MRI Safety Information
RABEA® PEEK implants are 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. Non-clinical trials demonstrated that the RABEA® (titanium) 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 3 T or less
• Maximum spatial magnetic fi eld gradient of 720 Gauss / cm or less
• Maximum mean whole-body specific absorption rate (SAR) stated by the MRI system of 2.9 W / kg
Under these examination conditions a temperature increase in the implant of max. 1.7° 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 15 mm around the RABEA® titanium implant 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
• 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 RABEA®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

Download PDF version: NUBIC

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 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 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.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain that often radiate through the shoulder and arm, and disturbances of sensation (numbness, oversensitivity, etc.).

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 bone 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 bone 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, mobilization, 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 bone 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.

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
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.

MRI Safety Information
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

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 NUBIC®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

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 tumor, 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).

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 stabilizes the cervical spine and, at the same time, allows a controlled range of movement between the vertebral bodies.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain 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 tumor which grow and multiply within or surrounding the spinal cord and / or spinal column. Spinal tumor can be benign (non-cancerous) or malignant (cancerous). Primary tumor originate in the spine or spinal cord, and metastatic or secondary tumor result from cancer spreading from another site to the spine.

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
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 RABEA® and 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, mobilization, 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 stabilization of the cervical spine. It serves to temporarily stabilize the spine until firm bone 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 colors for easy identification. Color changes are caused by factors related to production and reprocessing and do not affect the functionality.

MRI Safety Information
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

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 ASCOT®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

Download PDF version: TOSCA

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 tumors, 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).

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 stabilizes the cervical spine and, at the same time, allows a controlled range of movement between the vertebral bodies.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain 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 tumors which grow and multiply within or surrounding the spinal cord and / or spinal column. Spinal tumors can be benign (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.

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
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 RABEA® and 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.

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, mobilization, 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 TOSCA®
TOSCA® is a complete screw-plate-system for stabilization of the cervical spine. It serves to temporarily stabilize the spine until firm bone 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 colors for easy identification. Color changes are caused by factors related to production and reprocessing and do not affect the functionality.

MRI Safety Information
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

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 TOSCA®, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

Download PDF version: MOBIS II

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 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.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain that often radiate through the hips and legs, and disturbances of sensation (numbness, oversensitivity, etc.).

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 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® 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® 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® 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, mobilization, 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® II
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® 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.

MRI Safety Information
The MOBIS® II ST, MOBIS® PEEK has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of MOBIS® II ST, MOBIS® PEEK in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.

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® II, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

Download PDF version: TETRIS II

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 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.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain that often radiate through the hips and legs, and disturbances of sensation (numbness, oversensitivity, etc.).

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 bone 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 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™ 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™ 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™ 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, mobilization, 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™ II
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 bone 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™ II
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.

MRI Safety Information
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™ II, please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

Download PDF version: TASMIN R

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 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.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain that often radiate through the hips and legs, and disturbances of sensation (numbness, oversensitivity, etc.).

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 bone 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 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, mobilization, 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 bone 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.

MRI Safety Information
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).

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.

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.

Degeneration of the Disc
The spine is continually exposed to daily stresses and is also subject to natural aging. This process, called degeneration, can start as early as your 20s and can result in bulging (prolapse) of the discs and bone changes (e.g. bone spurs) of the joints of the spine and the openings through which the nerves exit. This can, in turn, exert pressure on the neighboring nerves or the spinal cord which can cause severe pain that often radiate through the hips and legs, and disturbances of sensation (numbness, oversensitivity, etc.).

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 inregard 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 bone 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.

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, mobilization, 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 bone 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.

MRI Safety Information
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.

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

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 VERTACONNECT , please report to the manufacturer SIGNUS Medizintechnik GmbH (qm@signus.com).

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.

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 are the intervertebral discs. Together with the ilium, the coccyx forms the sacroiliac joint (SIJ). 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.

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
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®).

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 colors. Color changes are due to production and processing and do not affect functionality.

MRI Safety Information
The DIPLOMAT® pedicle screw system has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of the DIPLOMAT® pedicle screw system in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction.

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).

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.