Product

SUNMAX COLLAGEN BONE GRAFT MATRIX

Sunmax Collagen Bone Graft Matrix is a mixture of collagen and synthetic ceramic of HAp / β-TCP. It is biodegradable and will gradually be replaced by new formed bone tissue. It is provided as a sterile, non-pyrogenic, single use, ready to use, implantable device that is intended for use as a bone void filler that is resorbed, remodeled and replaced by the growth of new bone during the course of the natural healing process for defects of the skeletal system.

SPECIFICATION ————————————————————————————————————————

B01011	10 mm × 10 mm × 10 mm, 1 pc/box
B01021	45 mm × 15 mm × 3mm, 1 pc/box
B01022	45 mm × 15 mm × 3mm, 2 pcs/box
B01031	8 mm × 15 mm, 1 pc/box
B01101	8 mm × 20 mm, 1 pc/box
B01111	10 mm × 15 mm, 1 pc/box
B01041	10 mm × 20 mm, 1 pc/box
B01051	1 cc, 1 vial/box
B01071	10 cc, 1 vial/box
B01081	20 cc, 1 vial/box
B01091	30 cc, 1 vial/box

INDICATION ————————————————————————————————————————

Sunmax Collagen Bone Graft Matrix, when coated with autogenous bone marrow, is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sunmax Collagen Bone Graft Matrix should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to bone. No defect should be greater than 30 mL. Sunmax Collagen Bone Graft Matrix provides a bone void filler that is resorbed and replaced with bone during the healing process.

CLINICAL STUDY
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DIRECTION FOR USE

PREOPERATIVE PROCEDURE

In the incidence of an open fracture, initial debridement and wound management should be performed. Exercise care to minimize periosteal stripping. Contaminated wounds must be treated and eradicated prior to the graft procedure. Use prophylactic antibiotic coverage as appropriate. All procedures should be performed in the operative room under aseptic conditions.

SURGICAL PROCEDURE

Follow accepted procedures for grafting with fixation. Bone marrow may be obtained from the iliac crest, using standard bone marrow collection techniques. If marrow from the fracture site is used, it is important that the marrow has not been contaminated.

Transfer Sunmax Collagen Bone Graft Matrix to a sterile tray, followed by the addition of sterile saline. Then allow Sunmax Collagen Bone Graft Matrix to hydrate for 1 to 3 minutes. After hydration, transfer Sunmax Collagen Bone Graft Matrix to another sterile tray containing bone marrow and coat all surfaces with marrow. Add 1 mL of bone marrow per mL of Sunmax Collagen Bone Graft Matrix. The Sunmax Collagen Bone Graft Matrix may be used directly or be molded to fit the defect shape. It is important to mold gently to avoid crushing the granules/ blocks/ strips/ plugs or damaging the marrow cells. The defect site should be filled as completely as possible. In weight bearing situations, Sunmax Collagen Bone Graft Matrix is to be used in conjunction with internal fixation devices.

CONTRAINDICATION

As with any bone grafting procedure, Sunmax Collagen Bone Graft Matrix is prohibited to be utilized in patients with current inflammatory bone disease such as osteomyelitis at the operative site.

Must not be used in patients with severe allergies manifested by a history of anaphylaxis, history of multiple severe allergies or known allergies against porcine collagen.

Must not be used in patients known to be undergoing desensitization injections to meat products, as these injections can contain porcine collagen.

Must not be used for fractures of the epiphyseal plate.

Must not be used in site with severe vascular or neurological impairment proximal to the graft site.

Must not be used in the presence of metabolic or systemic bone disorder

ADVERSE EVENTS

Possible adverse reactions may include but are not limited to the following: total resorption of the graft, malunion, pseudoarthrosis, hypersensitivity, bleeding at the bone marrow aspiration site, thrombophlebitis, embolus, and limb length discrepancies, loss of fixation, neurological complication, fracture of the implant, and deformity at site. As with any other orthopedical and grafting procedures, wound complications may occur, which include hematoma, edema, swelling and fluid accumulation, tissue thinning, infection, or other complications that are possible with any surgery.