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MARINER

MARINER
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MARINER

Product catalog summary
Introduction
The lumbar spine is composed of five vertebrae that protect the spinal cord and facilitate movement. Intervertebral discs, with a fibrous outer layer and a gelatinous center, are essential for spinal motion and stability.
Causes of Pain
Pain in the lumbar region can arise from factors such as aging, genetics, injury, or wear and tear, leading to conditions like herniated discs or spinal stenosis. Symptoms may include loss of motor function, tingling, numbness, and leg weakness.
Posterior Fixation
This surgical procedure stabilizes the lumbar spine using screws and rods to alleviate nerve pressure and encourage vertebral fusion. It is recommended for patients with Degenerative Disc Disease (DDD) who have not benefited from non-surgical treatments.
Preparing for Surgery
Preoperative evaluations may involve MRI, CT scans, or X-rays. Patients should adhere to their surgeon's preoperative instructions to reduce risks.
Surgical Procedure
The surgery consists of four steps: making an incision, decompressing affected areas, stabilizing with screws and rods, and allowing fusion. The goal is to relieve pressure and stabilize the spine.
Postoperative Expectations
After surgery, patients are monitored in recovery. They may need to wear a brace and follow a prescribed activity program. Surgeons provide guidance on wound care and activity limitations.
Potential Risks
Risks include implant issues, pain, infection, and severe complications such as paralysis or death. Patients should report any unexpected symptoms to their surgeon.
Technical Information
SeaSpine® offers various rod materials tailored to patient needs, including Titanium Alloy and Cobalt Chrome. Postoperative compliance is vital for recovery.
Implant Materials and Components
The document details various rods and screws available for the Mariner® and Malibu™ systems, including their sizes and specifications.
Product Specifications
The document lists surgical hooks and screws with specific dimensions and part numbers, such as Offset Hooks, Laminar Hooks, Pedicle Hooks, Uni Planar Dlta Screws, and ESS Plus Rods.
Contact Information
SeaSpine provides contact details for reporting serious incidents related to the devices, emphasizing the importance of reporting to both the manufacturer and the Therapeutic Goods Administration (TGA). Contact options include phone, fax, or email, with specific addresses for different regions.
Usage and Training
The document emphasizes that devices should only be used by surgeons with proper training. It includes a patient information leaflet to help patients understand treatment options and the risks associated with Posterior Fixation surgery.
Legal and Trademark Information
SeaSpine products are restricted to sale by or on the order of a surgeon. The document includes trademark information and legal disclaimers, noting that SeaSpine and its logos are registered trademarks.
Release Information
The document was released on December 31, 2021, and includes contact information for placing orders or seeking further information.
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Catalog excerpts

MARINER-1

POSTERIOR FIXATION PATIENT INFORMATION LEAFLET

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MARINER-2

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.

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MARINER-3

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.

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MARINER-4

Bone Graft WHAT IS POSTERIOR FIXATION? Posterior Fixation for the lumbar spine is a surgical procedure performed through an incision down the midline of your back. In this procedure, tissue is retracted or pulled back laterally to expose the affected vertebral bodies. Decompression may be necessary if the symptoms are caused by a compression of the spinal cord and/or nerve roots. Once decompressed, your surgeon will use screws and rods to stabilise or fixate the affected vertebral bodies. The primary goal of this procedure is to relieve pressure on the nerve roots and/or spinal cord to provide...

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MARINER-5

Mariner® Posterior Fixation Spinal Implant IS POSTERIOR FIXATION THE RIGHT PROCEDURE FOR ME? Your surgeon may have indicated that you are a candidate for a Posterior Fixation procedure. Mariner® is intended for skeletally mature patients with Degenerative Disc Disease (DDD). Some patients may have had at least six weeks of non-operative 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 disc between each vertebral body can lose their flexibility, height, and elasticity...

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MARINER-6

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.

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MARINER-7

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...

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MARINER-8

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...

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MARINER-9

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...

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MARINER-11

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...

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MARINER-12

Mariner® Implants PART NUMBER PART DESCRIPTION PART NUMBER PART DESCRIPTION Contoured Crossbar, Small, 5.5 Rod Contoured Crossbar, Medium, 5.5 Rod Contoured Crossbar, Large, 5.5 Rod Contoured Crossbar Small 6.0 Rod Contoured Crossbar Small 6.0 Rod Contoured Crossbar Medium 6.0 Rod Contoured Crossbar Large 6.0 Rod Polyaxial Head Extended Polyaxial Head Deformity Head Trauma Head

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MARINER-13

Mariner® Implants PART NUMBER PART DESCRIPTION PART NUMBER PART DESCRIPTION Extended Deformity Head Extended Trauma Head

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MARINER-14

Malibu™ Implants PART NUMBER PART DESCRIPTION PART NUMBER PART DESCRIPTION Closed Lateral Connector 5.5 x 30mm Closed Lateral Connector 5.5 x 45mm Closed Lateral Connector 5.5 x 60mm Polyaxial Reduct Screw 5.5 x 40mm Polyaxial Reduct Screw 5.5 x 45mm Polyaxial Reduct Screw 6.5 x 40mm Polyaxial Reduct Screw 6.5 x 45mm Polyaxial Reduct Screw 6.5 x 50mm Polyaxial Reduct Screw 7.5 x 40mm Polyaxial Reduct Screw 7.5 x 45mm Polyaxial Reduct Screw 7.5

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.