Indications, Safety, and Warnings Grafton DBM DBF
Caution: GRAFTON™ DBM DBF is restricted to use by a physician, podiatrist, or dentist. GRAFTON™ DBM DBF can be used in orthopedic or reconstructive bone grafting procedures. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. The contents of an individual GRAFTON™ DBM DBF container are intended for single patient use only. Do not use the contents of any container for multiple patients. Empty or partially used containers should be disposed of in accordance with recognized procedures for discarding medical waste materials. Preparation of the bone graft bed is important for graft incorporation and bone formation, as are other factors such as blood supply, source of marrow elements, loading, stability, and absence of infection at the graft site. The volume of graft material used in each procedure is determined by the judgment of the clinician.
This allograft may contain trace amounts of antibiotics (gentamicin) and processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or processing solutions.
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 a communicable 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 DBF must be reported promptly to Medtronic.
The presence of infection at the transplantation site is a contraindication for the use of this allograft.