Cambria Instructions for Use

QF-10-01-22-ENGL-C

Cambria™ - English European Representative mdi Europa GmbH Langenhagener Str.71 30855 Hannover-Langenhagen, Germany

Rx Only Caution: Federal Law restricts this device to sale by or on the order of physician Manufacturer: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008, USA

Telephone: +49 511 39 08 95 30 Fax: +49 511 39 08 95 39 Email: [email protected] Website: www.mdi-europa.com

Telephone: 760-727-8399 Fax: 760-727-8809 Complaints: [email protected] Customer Service: [email protected] Website: www.seaspine.com

CONTRAINDICATIONS Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery is a contraindication. The following conditions may reduce the chance of a successful outcome and should be taken into consideration by the surgeon. This list is not exhaustive:  Absolute contraindications:  Infection in or around the operative site  Allergy or sensitivity to implant materials  Any case not described in the indication  Relative contraindications:  Local inflammation  Morbid obesity  Pregnancy  Fever or leukocytosis  Prior fusion at the level(s) to be treated  Grossly distorted anatomy due to congenital abnormalities  Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis  Elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count  Any case not requiring bone graft and fusion or where fracture healing is not required  Patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition  Unsuitable or insufficient bone support

Lot Number (Batch Code)

Non-Sterile

Authorized Representative in the European Community

Caution, Consult Accompanying Documents

Product Complies with the Requirements of Directive 93/42/EEC  

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Bone immaturity The patient’s activity level, mental condition, occupation and/or a patient unwilling to cooperate with the postoperative instructions Any case where implant utilization would interfere with anatomical structures or expected physiological performance Use of incompatible components and/or materials from other systems

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IMPLANT MATERIALS PEEK-OPTIMA® LT1 and Tantalum radiographic markers

Catalog Number

Manufacturer

DESCRIPTION The SeaSpine Cambria is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. Implants are made from PEEK-OPTIMA® LT1 with tantalum radiographic markers and are generally box-shaped with a central canal for receiving bone graft material. Cambria is offered in a variety of shapes and sizes to accommodate variations in patient anatomy. INDICATIONS FOR USE Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3‐C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non‐operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Single Use Only

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 implant, with potential extrusion through the skin.  Dural leak requiring surgical repair.  Cessation of growth of the fused portion of the spine.  Subsidence of the implant into adjacent bone.  Loss of proper spinal curvature, correction, height and/or reduction.  Increased biomechanical stress on adjacent levels.  Improper surgical placement of the implant causing stress shielding of the graft or fusion mass.  Intraoperative fissure, fracture, or perforation of the spine.  Postoperative fracture due to trauma, defects, or poor bone stock.  Serious complications associated with any surgery may occur. These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death. WARNINGS AND PRECAUTIONS Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery. The safety and effectiveness of spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the spine secondary to severe spondylolisthesis, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other condition is unknown.

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Product Complies with the Requirements of Directive 93/42/EEC (Class I Devices Only) Consult Instructions for Use www.seaspine.com/eIFU Material

The implantation of this system should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient. Based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of the system Ensure all implants, components or instruments are sterilized prior surgery. The use of non-sterile devices may lead to inflammation, infection or disease. Implants should never be reused under any circumstances. A used implant should be discarded. While the implant may appear undamaged, it may have small defects or internal stress patterns and if implanted, could fail to perform as intended and pose safety risks to the patient. The risks include, but are not limited to, mechanical failure, breakage, difficulty with implantation, incompatibility with mating components and infection.

MRI SAFETY This device has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of this device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. CLEANING AND DECONTAMINATION All instruments and implants that have been previously taken into a sterile surgical field must be decontaminated and cleaned using established hospital methods before sterilization and reintroduction into the sterile surgical field. The following recommendations are for the manual cleaning and decontamination of surgical instruments. These recommendations are considered guidelines with the ultimate responsibility for verifying adequate cleaning remaining with the user. Automated cleaning systems differ between hospitals and therefore must be qualified by the hospital. Manual Cleaning Procedure Remove all gross visible soil with a damp gauze 1 pad or wipe. Prepare an enzymatic cleaning solution (such as 2 Prolystica® 2X Enzymatic) per manufacturer’s instructions.

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Immerse the instruments in the cleaning solution and actuate all features so the enzymatic cleaner contacts all mated surfaces and soak for 15 minutes.

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Transfer the instruments to fresh cleaning solution (such as Prolystica® 2X Enzymatic). Thoroughly scrub all instruments with a soft bristle cleaning brush while immersed in the enzymatic cleaning solution. Be sure that Page 1 of 2