PRECAUTIONSĮxtensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Therefore, caution should be exercised in using GRAFTON PLUS™ DBM Paste in a patient with a starch allergy and/or amylase deficiency. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.
This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Note: The user should consider the fact that GRAFTON™ DBM CRUNCH contains demineralized bone chips approximately 3 mm (☑ mm) in determining the appropriateness of this allograft for use in small defects.
GRAFTON™ DBM and GRAFTON PLUS™ DBM are absorbed/remodeled and replaced by host bone during the healing process. GRAFTON™ DBM and GRAFTON PLUS™ DBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON™ DBM and GRAFTON PLUS™ DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or they may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy) dental extraction sites (ridge maintenance, implant preparation/placement) sinus lifts cystic defects craniofacial augmentation. GRAFTON™ DBM (excluding the Orthoblend form) and GRAFTON PLUS™ DBM are also intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral, and cranio-/maxillofacial defects. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON™ DBM and GRAFTON PLUS™ DBM are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. GRAFTON™ DBM and GRAFTON PLUS™ DBM INDICATIONS FOR USE
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