ANTERIOR CERVICAL DISCECTOMY AND 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.

Bone Graft Material Plate Spacer WHAT IS AN ANTERIOR CERVICAL DISCECTOMY AND FUSION? An Anterior Cervical Discectomy and Fusion (ACDF) is a surgical procedure to remove a herniated or degenerative disc in the neck. In this procedure, an incision is made in the neck area to reach and remove the unhealthy disc, then replaced with a spacer and fixated with screws and/or a plate. Bone graft or bone graft substitute is inserted to fuse the bones together above and below the disc. The primary goal of this procedure is to relieve pressure on the nerve roots and/or spinal cord. The long-term goal of...

Shoreline® ACS Spinal Implant IS AN ANTERIOR CERVICAL DISCECTOMY AND FUSION THE RIGHT PROCEDURE FOR ME? Your surgeon may have indicated that you are a candidate for an Anterior Cervical Discectomy Fusion (ACDF). Shoreline® ACS is intended for skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine (C2-C7). Some patients may have had at least six weeks of nonoperative treatment from the beginning of their symptoms and are still experiencing arm pain and/or neurological symptoms. The Shoreline system is comprised of an intervertebral spacer that is used to fill 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 After you are sedated, positioned, and covered by surgical draping, an X-ray image is taken of your spine to identify the location of the operative disc space. STEP 1: APPROACH The surgeon will make a small incision on the anterior (front) of your neck. Once the optimal path has been determined, a retractor will be utilised to hold the skin incision open, providing access and visibility to the affected area. STEP 2: DISC REMOVAL Once the operative level has been exposed, the surgeon will then begin to remove the damaged or diseased disc. STEP 3: IMPLANT An appropriately...

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. • Dural leak requiring surgical repair. • Cessation of growth of the...

TECHNICAL INFORMATION Shoreline® 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. Shoreline 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 IMPLANT MATERIALS • Polyetheretherketone (PEEK) per ASTM F2026 • Commercially...

TruProfile® Interbody PART NUMBER PART DESCRIPTION No-profile Interbody PART NUMBER PART DESCRIPTION 16 x 14 x 6mm through 12mm, 7º, No-profile Integrated Spacer 18 x 15 x 6mm through 12mm, 7º, No-profile Integrated Spacer No-profile Locking Cap PART NUMBER PART DESCRIPTION 6-7mm, No-profile Locking Cover, 8–12mm TruProfile Plate PART NUMBER PART DESCRIPTION TruProfile Locking Cover PART NUMBER PART DESCRIPTION 5–12mm, Locking Cover Backup Screws PART NUMBER PART DESCRIPTION

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....