INFUSE BONE GRAFT

Additional Manufacturer Narrative

PRODUCTS FROM MULTIPLE MFRS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNK IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Description of Event or Problem

IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE PT UNDERWENT A GRAFTING PROCEDURE IN THE #3 TOOTH AREA USING TITANIUM MESH AND RHBMP-2/ACS. SIX MONTHS POST-OP, THE MESH HAD BECOME EXPOSED, AND A SURGICAL PROCEDURE WAS CONDUCTED TO REPAIR THE SITE. DURING THE SURGERY, THE HCP NOTED THAT ALTHOUGH SOME BONE FORMED, PRIMARILY THE GRAFTED AREA SHOWED A "GREEN BLOB" OF "GRANULATION MATERIAL". THE MATERIAL WAS DEBRIDED AND SENT TO PATHOLOGY FOR TESTING. RESULTS ARE NOT AVAILABLE AT THIS TIME. THE HCP IS ANTICIPATING THAT THE PT WILL RETURN TO THE OR AT A LATER TIME FOR MORE DEFINITIVE SURGERY.