POSTERIOR REVISION PATIENT INFORMATION LEAFLET

INTRODUCTION The lumbar spine is made up of five bones called vertebrae. 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 lower back. 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 lower extremities, radiating pain, and weakness and/or numbness in your legs.

Mariner® Outrigger® Posterior Fixation Spinal Implant WHAT IS A POSTERIOR REVISION? Posterior Revision for the lumbar spine is a surgical procedure performed in certain patients to correct the problems of earlier spine surgery. Revision surgery is indicated in patients with chronic pain even after surgery. Failed back syndrome or failed back surgery is a condition used to describe persistent back pain following back surgeries. The primary goal of revision spine surgery is to reduce pain and resume normal activities. The revision spine surgery is performed in certain conditions, such as re-herniation...

IS A POSTERIOR REVISION THE RIGHT PROCEDURE FOR ME? Your surgeon may have suggested that you are a candidate for a posterior revision procedure. Mariner® Outrigger® is intended for skeletally mature patients to assist with fusion surgery for conditions such as failed previous fusion, Degenerative Disc Disease (DDD), spondylolisthesis, and spinal stenosis. FAILED PREVIOUS FUSION Failed previous fusion, or pseudarthrosis, happens when a spinal fusion is unsuccessful. In cases of pseudarthrosis, not enough bone formation occurs during the mending period. DEGENERATIVE DISC DISEASE (DDD) During the...

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 midline of your back. A retractor will be utilised to hold the skin incision open, providing access and visibility to the affected area. 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...

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 surgeon will determine the best postoperative course for you. The day after your surgery, your surgeon 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 surgeon may ask you to carefully sit, stand, or...

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 SeaSpine® offers a wide range of rod materials to accommodate each patient’s needs. With straight and pre-contoured rod options, there are rods available for the most complex cases. The different rod characteristics, such as rod stiffness, bending strength and springback will allow your surgeon to pick the correct rod for your case. 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...

Mariner® Outrigger® Implants PART NUMBER PART DESCRIPTION Parallel, Side-Loading/Closed, Variable 8mm Parallel, Top Loading/Closed, Variable 10mm Parallel, Closed, Variable 8mm Closed, Axial Rod, Long, 120m

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 surgeons having received proper training in the use of the device....