PRECLINICAL AND CLINICAL EVIDENCE BONE GRAFTING (ORAL MAXILLOFACIAL AND DENTAL)

INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTION FOR INFUSE BONE GRAFT FOR CERTAIN ORAL MAXILLOFACIAL AND DENTAL REGENERATIVE USES

INFUSE^® Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.

The INFUSE^® Bone Graft consists of two components–recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in the package insert.

INFUSE^® Bone Graft is contraindicated for consumers with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in consumers with any active malignancy or consumers undergoing treatment for a malignancy, in pregnant women, or consumers with an active infection at the operative site.

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device.

INFUSE^® Bone Graft has not been studied in patients who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.

CONTRAINDICATIONS: MASTERGRAFT GRANULES

This product is not intended to provide structural support during the healing process, therefore, Mastergraft Granules is contraindicated where the device is intended as structural support in the skeletal system.

Conditions representing relative contraindications include:

• Severe neurological or vascular disease
• Uncontrolled diabetes
• Hypercalcemia
• Pregnancy
• Where stabilization of fracture is not possible
• Segmental defects
• Where there is significant vascular impairment proximal to the graft site
• When there are systemic and/or metabolic disorders that affect the bone or wound healing
• Any patient unwilling to follow postoperative instructions
• Any case not described in the indications

POTENTIAL ADVERSE EVENTS: MASTERGRAFT GRANULES

A listing of potential adverse events includes, but is not limited to:

• Deformity of the bone at the surgical site
• Fracture or extrusion of the Mastergraft Granules, with or without generation of particulate debris
• Wound complications including hematoma, site damage, infection, bone fracture, and other complications common to any surgical procedure
• Incomplete or lack of osseous ingrowth into bone void, as possible with any bone filler