Indications for Use: The BEAR Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.
Contraindications: 1) The BEAR Implant is not designed, sold, or intended for use except as described in the indications for use. 2) The BEAR Implant is contraindicated for use in any patient with a known allergy to bovine collagen, bovine gelatin or other bovine-derived products.
Warnings: 1) For single (patient) use only. Do not reuse, reprocess or re-sterilize this product. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the implant and/or create a risk of contamination of the device which could result in patient injury, illness or death. Cleaning, disinfection and re-sterilization may compromise the essential material and design characteristics of the implant leading to failure. 2) Do not use the implant if either the outer foil pouch or the inner (Tyvek®/polyester) pouch is perforated or torn. 3) The device is composed of bovine collagen. The potential for development of bovine collagen antibodies as a result of device implantation exists. 4) If the implant becomes wet with saline or any fluid other than autologous blood on the surgical field, discard and use another BEAR Implant.
Potential Adverse Events: The same potential medical/surgical complications that apply to any orthopaedic surgical procedure, such as ACL reconstruction, may occur during or following implantation of the BEAR Implant. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. Additional surgery may be required to correct some of the adverse effects. The following potential adverse effects (e.g., complications) may be specifically associated with use of the BEAR Implant: 1) Implant rejection or allergic reaction to the BEAR Implant. 2) As with any medical device derived from animal tissue, the potential for transmission of infectious agents, such as viruses or agents that transmit TSE, exists.
Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.