VENTURA™ NANOMETALENE POSTERIOR LUMBAR INTERBODY FUSION 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.

Ventura™ NanoMetalene® Spinal Implant WHAT IS A POSTERIOR LUMBAR INTERBODY FUSION? A Posterior Lumbar Interbody Fusion (PLIF) for the lumbar spine is a surgical procedure that attempts to eliminate instability and relieve pain in the lower back and lower extremities. This procedure is performed through an incision down the midline of your back tissue. The unhealthy disc is removed, then replaced with a synthetic spacer, screws and rods for added stabilisation. The Ventura™ NanoMetalene® Implant is an intervertebral spacer that is used to fill the area where your disc has been removed. This spacer...

Bone Graft Materaial IS A POSTERIOR LUMBAR INTERBODY FUSION THE RIGHT PROCEDURE FOR ME? Your surgeon may have indicated that you are a candidate for a for a posterior lumbar interbody fusion. This procedure is intended for skeletally mature patients with Degenerative Disc Disease (DDD), spondylolisthesis, or spinal stenosis of the lumbar spine (L2-S1). 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 process, 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. The size of the incision can vary based on the number of vertebral levels and/or complexity of your case. STEP 2: SCREW PLACEMENT AND DECOMPRESSION Your surgeon will...

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 Ventura™ NanoMetalene® implants are made of a biocompatible material known as PEEK, with small tantalum markers used to help the surgeon clearly see the implant through X-ray images. These implants also have a one-micron thick layer of commercially pure titanium, known as NanoMetalene. • Submicron titanium layer bonded to entire PEEK implant. • Titanium surfacing resists wear debris.¹ • Radiolucent for post-op fusion assessment.² • Mechanical properties of PEEK unaltered, providing stiffness on par with bone.¹ Although the Ventura™ NanoMetalene® implant is intended to be...

PART NUMBER PART DESCRIPTION PART NUMBER PART DESCRIPTION Ventura NanoMetalane Implant, 9 x 24 x 8mm, Lordotic Ventura NanoMetalene Implant, 9 x 28 x 8mm, Lordotic Ventura NanoMetalene Implant, 9 x 24 x 9mm, Lordotic Ventura NanoMetalene Implant, 9 x 28 x 9mm, Lordotic Ventura NanoMetalene Implant, 9 x 24 x 10mm, Lordotic Ventura NanoMetalene Implant, 9 x 28 x 10mm, Lordotic Ventura NanoMetalene Implant, 9 x 24 x 11mm, Lordotic Ventura NanoMetalene Implant, 9 x 28 x 11mm, Lordotic Ventura NanoMetalene Implant, 9 x 24 x 12mm, Lordotic Ventura NanoMetalene Implant, 9 x 28 x 12mm, Lordotic Ventura...

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....