Indications, Safety, and Warnings Grafton DBM, Grafton Plus DBM

GRAFTON DBM and GRAFTON PLUS DBM

INDICATIONS FOR USE

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. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. 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. 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 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. 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 are absorbed/remodeled and replaced by host bone during the healing process. Note: The user should consider the fact that GRAFTON™ DBM CRUNCH contains demineralized bone chips approximately 3 mm (±1 mm) in determining the appropriateness of this allograft for use in small defects.

CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. GRAFTON PLUS™ DBM Paste contains starch. Therefore, caution should be exercised in using GRAFTON PLUS™ DBM Paste in a patient with a starch allergy and/or amylase deficiency.

PRECAUTIONS

Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Despite the viral inactivation and extensive tissue donor selection and qualification processes used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to GRAFTON™ DBM or GRAFTON PLUS™ DBM must be reported promptly to Medtronic. Adequate fixation should be used to stabilize the implant site during bone formation and healing in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities). If injecting GRAFTON™ DBM or GRAFTON PLUS™ DBM into the defect site, precaution should be taken not to: 

  • Over-pressurize the delivery device, as this may lead to extrusion of the device beyond the site of its intended application and damage to the surrounding tissues. 
  • Over-pressurize the defect site, as this may lead to fat embolization or embolization of the device material into the bloodstream. 

When used as a bone graft extender in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities), GRAFTON PLUS™ DBM Paste is intended for use only with autograft, not other allograft. Recommended ratios of GRAFTON PLUS™ DBM Paste to autograft as a bone graft extender are 1:1 or 2:1.

CONTRAINDICATIONS

The following are contraindications for the use of GRAFTON™ DBM and GRAFTON PLUS™ DBM:

  • The presence of infection at the transplantation site.
  • Treatment of spinal insufficiency fractures.