POSTERIOR CERVICAL FUSION PATIENT INFORMATION LEAFLET

INTRODUCTION The cervical spine is made up of seven bones called vertebrae. These vertebrae start at the base of the skull and extend through the entirety of the neck. The bones and joints contain and protect the spinal cord, while also allowing motion such as bending and twisting. The main joint between two vertebrae is called a disc. Each disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosus), and a soft, gelatinous centre (nucleus pulposus). These two parts play a vital role in allowing and restricting motion.

WHAT IS CAUSING MY PAIN? Age, genetics, injury, and everyday wear and tear caused by routine activities can contribute to damage and deterioration of the discs in your neck. Your surgeon may have diagnosed a herniated disc, disc degeneration, spinal stenosis, or loss of disc height as compared to your other discs. Symptoms of these conditions can include loss of motor function and dexterity, tingling or numbness in the arm or hand, and radiating pain, weakness and/or numbness in your shoulders, arms and neck.

Occipital Plate NorthStar® OCT Posterior Cervical Fixation WHAT IS A POSTERIOR CERVICAL FUSION? Posterior Cervical Fusion is a surgical procedure that attempts to eliminate instability and relieve pain in the neck. In this procedure, an incision is made on the back of the neck. Tissue and muscles are retracted to expose the affected vertebral bodies. Decompression may be necessary if symptoms are caused by a compression of the spinal cord and/or nerve roots. Once the proper anatomy has been decompressed, your surgeon will use screws and rods to stabilize or fixate the affected vertebral bodies....

NorthStar® OCT Posterior Cervical Fixation IS A POSTERIOR CERVICAL FUSION THE RIGHT PROCEDURE FOR ME? Your surgeon may have indicated that you are a candidate for a Posterior Cervical Fusion. This surgical procedure is intended for skeletally mature patients with Degenerative Disc Disease (DDD), spondylolisthesis, or spinal stenosis of the cervical spine (C2-C7). Some patients may have had at least six months of nonoperative treatment from the beginning of their symptoms and are still experiencing arm pain and/or neurological symptoms. DEGENERATIVE DISC DISEASE (DDD) During the natural aging...

PREPARING FOR SURGERY Your surgeon will provide a clinical examination and may conduct some diagnostic tests to ensure you are a candidate for the procedure. These may include MRI, CT scans, and/or X-rays. Your surgeon may provide you with guidance on what to do or not do before your procedure. It is important that you follow your surgeon’s recommendations in preparation of your surgical procedure.

WHAT TO EXPECT DURING SURGERY DURING SURGERY After you are sedated, positioned face down, and surrounded by the appropriate surgical draping, an X-ray image is taken of your spine to identify the location of the operative disc space. STEP 1: APPROACH Your surgeon will make a small incision down the back of your neck. The size of the incision can vary based on the number of levels and/or complexity of your case. STEP 2: DECOMPRESSION Your surgeon may decide that decompression of the affected vertebrae and discs may be necessary to reduce pressure from the cord or symptomatic nerve root. During...

WHAT TO EXPECT AFTER SURGERY After surgery you will wake up in the recovery room, where your vital signs will be monitored, and your immediate postoperative condition will be carefully observed. Once the medical staff feels that you are doing well, you will be returned to your room in the hospital. Your physician will determine the best postoperative course for you. The day after your surgery, your physician may instruct you to use a brace for a period of time to assist with the spinal fusion process. Supervised by trained medical professionals, your physician may ask you to carefully sit, stand,...

WHAT ARE THE POTENTIAL RISKS? POSSIBLE ADVERSE EVENTS Like other spinal system implants, the following adverse events are possible. This list is not exhaustive. • Delayed union or nonunion (pseudarthrosis). • Bending, disassembly or fracture of implant and components. • Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain. • Pain, discomfort, or abnormal sensations due to the presence of the device. • Pressure on skin where inadequate tissue coverage exists over the...

TECHNICAL INFORMATION The SeaSpine® comprehensive posterior cervical systems offer a variety of screws and rods to accommodate varying patient pathologies. These screws and rods are comprised of various materials and although rare, metal sensitivities and allergic reactions to foreign materials have been reported for orthopedic implant patients. The most common sensitivities, in order of their frequency, are to nickel, cobalt, and chromium. Implant sensitivity reactions to titanium and titanium alloy are much less common. IMPLANT MATERIALS • Titanium Alloy (Ti Alloy) – ASTM F136 • Cobalt Chrome...

NorthStar® OCT Implant Set PART NUMBER PART DESCRIPTION PART NUMBER PART DESCRIPTION Polyaxial Screw, Favored Angle 4.5 x 24mm Polyaxial Screw, Favored Angle 4.5 x 26mm Polyaxial Screw, Favored Angle 4.5 x 28mm Polyaxial Screw, Favored Angle 4.5 x 30mm Polyaxial Screw, Favored Angle 4.5 x 32mm Polyaxial Screw, Favored Angle 4.5 x 34mm Polyaxial Screw, Favored Angle 5.5 x 24mm Polyaxial Screw, Favored Angle 5.5 x 26mm Polyaxial Screw, Favored Angle 5.5 x 28mm Polyaxial Screw, Favored Angle 5.5 x 30mm Polyaxial Screw, Favored Angle 5.5 x 32mm Polyaxial Screw, Favored Angle 5.5 x 34mm Smooth Shank...

CONTACT INFORMATION A notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the TGA. Any serious incident that occurs in relation to the device should be reported to SeaSpine® via phone, fax, or email. When possible, retain the product involved in the complaint and return to SeaSpine as instructed by SeaSpine Customer Service; [email protected] and the Therapeutic Goods Administration (TGA) www.tga.gov.au. SeaSpine intends that this device should be used only by physicians having received proper training in the use of the device....