Balboa Instructions for Use

QF-10-01-05-ENGL-B

Balboa™ - 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: +1-760-727-8399 Fax: +1-760-727-8809 Complaints: [email protected] Customer Service: [email protected] Website: www.seaspine.com

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

IMPLANT MATERIALS Titanium alloy as described by ASTM F136 (Ti 6A1-4V ELI). 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

Catalog Number

Lot Number (Batch Code)

Non-Sterile

Authorized Representative in the European Community

Caution, Consult Accompanying Documents

Manufacturer

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

DESCRIPTION The SeaSpine Balboa system consists of single hole plates and bone screws. The plate is placed on the anterior aspect of the vertebral body and the screw is threaded through the plate into the vertebral body. A segment of the plate overhangs the adjacent disc space providing a buttressing effect. The implants are made from surgical implant grade titanium alloy as described by ASTM Standard F-136 (Ti 6A1-4V ELI). INDICATIONS FOR USE The Balboa anterior lumbar buttress system is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Single Use Only

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Unsuitable or insufficient bone support 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 materials from other systems

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

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Product Complies with the Requirements of Directive 93/42/EEC (Class I Devices Only) Material

Consult Instructions for Use www.seaspine.com/eIFU

fusion (pseudarthrosis). The safety and effectiveness of these devices for any other condition is unknown.  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.  This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.  Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in building a construct. 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 1 gauze pad or wipe. Prepare an enzymatic cleaning solution (such 2 as Prolystica® 2X Enzymatic) per manufacturer’s instructions. Page 1 of 2