Cervical Artificial Disc Patient Information

2 ■ SECURE®-C Patient Information

SECURE®-C Patient Information ■ 3

Cervical Artificial Disc Patient Information This brochure is intended to provide you with information about a treatment option for your arm pain and/or neurologic symptoms (such as weakness or numbness). After reviewing and discussing your medical history, x-rays, and the results of other evaluations you have completed, you and your doctor have determined that an option for improving your condition would be to undergo cervical spine (neck) surgery using the SECURE®-C Cervical Artificial Disc made by Globus Medical, Inc. SECURE®-C Patient Informati

What is the SECURE®-C Cervical Artificial Disc? The SECURE®-C Cervical Artificial Disc consists of two metallic endplates (cobalt chromium molybdenum alloy, CoCrMo) and a polyethylene (plastic) inner core. The materials used in the device are commonly used in orthopedic implants. The two endplates are secured to the top and bottom surfaces of the involved vertebrae (the bones in the spine) and the core fits between them. The implanted device is designed to allow motion at the treated level as the plastic core moves against the metallic endplates. Specifically, SECURE®-C’s design is intended to...

Facet Joint Disc What is the cervical spine and how does it normally move? Your spine is one of the most important parts of your body. It gives your body structure, support, stability, flexibility (motion or movement in a joint) and provides protection for your spinal cord. A normal spine allows you to move about freely and to bend with flexibility. Your neck, or cervical spine, is composed of seven bones (vertebrae) which are numbered C1 to C7 and are stacked on top of each other to form a column. Each vertebrae has a hole for the spinal cord which contains nerves that carry signals from your...

What is causing my arm and neck symptoms? Age, genetics, injury, and everyday wear and tear caused by routine activities can contribute to damage and deterioration (degeneration) of the discs in your neck. Degeneration commonly causes pain that radiates toward the shoulders and arms and/or weakness and numbness and may also cause neck pain. Your doctor has probably taken X-rays and an MRI or CT of your neck and may have found a herniated disc (a disc bulge as shown in the illustration below), spondylosis (degeneration of the vertebral joint causing stiffness), or narrowing of the disc as compared...

Flexion The SECURE®-C design permits motion in flexion and in extension. How is surgery with the SECURE®-C Cervical Artificial Disc different from a fusion? The current standard of care for the surgical treatment of cervical disc disease is fusion (joining of two bones together), which is known as anterior cervical discectomy and fusion (ACDF). In both an ACDF and a SECURE®-C Cervical Artificial Disc procedure, the unhealthy disc is removed and the height at that level is restored to relieve pressure on the nerves and/or spinal cord. In an ACDF, after the unhealthy disc is removed, it is replaced...

How is surgery with the SECURE®-C Cervical Artificial Disc different from a fusion? (cont’d) The SECURE®-C Cervical Artificial Disc has been developed to provide pain relief while potentially allowing motion of the cervical spine. In a SECURE®-C procedure, after the unhealthy disc is removed, it is replaced with the device alone (no bone graft). The device is designed to provide support for the vertebrae while potentially allowing motion in backward and forward bending, side-to-side bending, and turning. Who should receive the SECURE®-C Cervical Artificial Disc? The SECURE®-C Cervical Artificial...

Who should not receive the SECURE®-C Cervical Artificial Disc? (Contraindications) You should avoid having surgery with the SECURE®-C Cervical Artificial Disc if you are experiencing any of the following conditions: • Active systemic (whole body) infection or an infection at the operating site, as undergoing surgery could interfere with your ability to heal and could increase the chance of spreading or worsening the infection • Osteoporosis or osteopenia (thin or weak bones resulting from a loss of calcium) because this condition could increase the risk of bone fracture, or could cause the device...

What are the WARNINGS and PRECAUTIONS associated with the SECURE®-C device? WARNINGS There was a clinical study in the United States to evaluate patients treated with the SECURE®-C Cervical Artificial Disc. To participate in the clinical study, patients had to meet certain criteria. For example, patients could not be included in the study if they were taking medications known to interfere with bone healing (such as steroids), if they had a prior surgery at the level being treated, if they had a prior fusion surgery next to the level being treated, or if they were pregnant. As a result, it is...

What are the WARNINGS and PRECAUTIONS associated with the SECURE®-C device? (cont’d) • Disease or degeneration of the facet joint at the level of the spine to be treated; • Neck or arm pain of unknown cause; • Neck pain alone; • Paget’s disease (enlarged bones), osteomalacia (weakened bones), or other metabolic bone disease (chemical imbalance); • Rheumatoid arthritis (chronic joint inflammation) or other autoimmune disease (abnormal body response to normal substances); • Neuromuscular disorders such as muscular dystrophy (progressive loss of muscle), spinal muscular atrophy(decreased muscle),...

What are the potential RISKS and ADVERSE EFFECTS associated with the SECURE®-C Cervical Artificial Disc? Complications may occur when you are treated with the SECURE®-C Cervical Artificial Disc, as with any surgery. Possible complications may include but are not limited to the following: • Nerve damage • Neck and/or arm pain • Allergic reaction to the implant material • Implant components bending, breaking, loosening or moving • Instruments bending or breaking • Infection of your surgical wound, disc, bone, or surrounding soft tissue • Systemic infection • Nerve or spinal cord injury, possibly...