Description: Unilab Surgibone® is a sterile, extracellular composite of hydroxyapatite and collagen of bovine bone for surgical implantation in humans. The chemical composition of Unilab Surgibone is that of hydroxyapatite approximated by the formula: 3Ca3 (PO4)2 Ca (OH)2 . It contains approximately 20-29% protein in the form of Type I collagen. Unilab Surgibone® is cut from natural mature bovine bone obtained from government inspected abattoirs in the United States from animals passed as fit for human consumption. Taking medical implantation requirements into consideration, each size is cut from specially selected bone, thus retaining its physical form. Various animal tests, experimental tests as well as clinical investigations that have been conducted for more than 15 years have demonstrated that Unilab Surgibone® does not produce cytotoxic or systemic effects. During these tests Unilab Surgibone® has shown no evidence of antigenicity or immunogenicity. Unilab Surgibone® is pyrogen-free. Tests have shown that the processing methods used reduce or eliminate various transmissible agents when the bone was inoculated with these agents.

Indications: Cancellous Unilab Surgibone® can be used for orthopedic applications such as cervical or lumbar fusion, skeletal reconstruction, osteotomy procedures and cavity filling. Unilab Surgibone® onlay grafts can be utilized for maxillo-facial surgery, cranioplasty, cavity filling, reconstructions, etc.

Contra-Indications: Unilab Surgibone® should not be used in any patient with history of extreme allergies or shows local or general state of infection. Unilab Surgibone® should not be used in any patient who exhibits certain types of psychological instability or displays a lack of understanding, appropriate motivation or attitude toward implantation. The aforementioned are general, relative contra-indications and each individual patient must be evaluated by his or her surgeon to determine the specific risk-to-benefit ratio.

Utilization: Unilab Surgibone® is supplied sterile in various shapes and sizes to meet surgical requirements and may be carefully modified by normal shaping instrumentation.Unilab Surgibone® should be rinsed with red bone marrow, patient’s blood or isotonic saline solution just before implantation. Unilab Surgibone® should be gently pressed or lightly tapped into place. If forced or driven into place, the graft may crack or fracture and the implant site may be damaged. Load-bearing grafts are marked with a slot, which should always be inserted so that the slot is parallel to the direction of greatest force or pressure. All cancellous Unilab Surgibone® must be securely implanted and properly fitted to the patient’s bone (cancellous to cancellous bone) in order for vascularization to take place.If needed, Unilab Surgibone® can be tightly secured in place by osteosynthesis, especially onlay grafts.

Warnings:
• Unilab Surgibone® should not be re-sterilized.
• Extreme care with strict adherence to aseptic techniques must be employed to prevent contamination of
  the implant and possible complications at the implant site.
• The use of drugs or other medical therapies reported in medical literature in connection with Unilab
  Surgibone® must be the responsibility of the surgeon.
• Although Unilab may suggest particular uses for Surgibone as a result of reports from doctors, the final
  selection and applications are the responsibility of the surgeon and should be consistent with acceptable
  surgical practice.
• Non load-bearing bones must not be used in areas requiring load-bearing bones.

Possible Adverse Reactions & Complication: Any patient undergoing a surgical procedure may be subject to unforeseen intraoperative and postoperative complications. Each patient’s tolerance to surgery, medication and implantation of a foreign body may be different. It is the surgeon’s responsibility to provide the patient with all appropriate information prior to surgery. Risks versus benefits, adverse reactions
and complications associated with surgery and implantation should be discussed with the patient to determine his or her understanding prior to
surgery.

Possible common adverse reactions and complications that may result with the use of this product are listed below:
Infection: When diagnosed, an appropriate regimen of treatment should begin. If the infection cannot be controlled at the site, it may necessitate
the removal of the implant.
Hematoma: Meticulous hemostasis during surgery is principle measure of prevention. Hematomas are possible precursor to infection and
increased fibrosis. The surgeon must weigh carefully the alternatives of evacuation of the hematoma or its spontaneous reabsorption.
Serous Fluid Accumulation: A serous accumulation may be a sign of local tissue allergy when diagnosed. Evacuation of fluid accumulation
should be accompanied with cytologic tests. However, persistent fluid accumulation may necessitate removal of implant.
Fracture of the Implant: Unilab Surgibone® implants designed for stress sites should always be inserted in load-bearing areas with the slot in the direction of the greatest pressure or force and must be secured and properly fitted to the patient’s bone (cancellous to cancellous bone). Unilab Surgibone® should be gently pressed or lightly tapped into place. If they are forced or driven into place, the graft may crack or fracture and the implant site may be damaged.
Lack of Fusion: In order to facilitate bone growth, vascularization and reduce risks of non-fusion, it is essential the Unilab Surgibone® be inserted in a sterile, surgical site with the implant firmly secured and properly fitted to the patient’s bone for stability. (Non-fusion is rare, but stability of the area may be achieved by fibrous union.) Extreme complications may require removal of the implant. Bone absorption, fragmentation and other similar problems normally associated with autologous or homologous bone implants may occur.
Caution:
- Unilab Surgibone® are supplied sterile.
- Do not use if package is opened or damaged outside of the operating room.
- Single use only - do not re-sterilize.
- Do not store below 0°C (32°F) or above 60°C (140°F).