GRAFTON DBM GEL

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT RECEIVED DBM BONE VOID FILLER DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT CLAVICLE. AFTER AN UNDISCLOSED PERIOD OF TIME, HE REPORTEDLY DEVELOPED "AN INFECTION AND CELLULITIS," AND WAS SEEN BY AN INFECTIOUS DISEASE SPECIALIST. THE PATIENT WAS REPORTEDLY ON ¿MANY WEEKS OF IV ANTIBIOTICS WITHOUT IMPROVEMENT.¿ THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE HARDWARE, AND ALSO UNDERWENT "A NUMBER OF INCISION AND DEBRIDEMENTS OF THE AREA, AS WELL AS REMOVAL OF SOME OF THE INFECTED BONE." NO DATES WERE PROVIDED. DUE TO "CONTINUED PAIN, NONUNION AND REDNESS AT THE SITE", A BONE BIOPSY WAS TAKEN. AN ANTIBIOTIC SPACER WAS IMPLANTED INTO THE AREA, BUT REMOVED WHEN IT WAS NOT SUCCESSFUL. A VASCULARIZED GRAFT (USING MUSCLE FROM THE FIBULA) WAS REPORTEDLY PERFORMED, AND AN ANASTOMOSIS WAS DONE AT THE CLAVICLE. ¿ONLY AFTER THIS LAST PROCEDURE WAS DONE DID HE HAVE HEALING OF HIS BROKEN COLLAR BONE.¿ THE PATIENT REPORTEDLY HAD FOLLOW UP SKIN GRAFTING AS WELL.

Additional Manufacturer Narrative

THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE REPORTER. (B)(6). (B)(4). ALL DONOR AND MANUFACTURING RECORDS RELATIVE TO THE SUBJECT GRAFT WERE REVIEWED AND INDICATED THAT THE GRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. THE DONOR TISSUE WAS CONFIRMED ELIGIBLE FOR TRANSPLANTATION. THE DONOR TISSUE WAS PRE-TREATED WITH GAMMA IRRADIATION PRIOR TO PROCESSING. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO THE MANUFACTURER WAS NOTIFIED OF THIS INCIDENT, AND THEY HAVE RECEIVED NO ADDITIONAL REPORTS OF INFECTION INVOLVING ANY OTHER TISSUES PROCURED FROM THIS DONOR. THE MANUFACTURER HAS NOT RECEIVED ANY OTHER REPORTS OF INFECTION INVOLVING ANY OTHER GRAFTS MANUFACTURED FROM THIS LOT OR FROM THIS DONOR TISSUE. BASED ON THESE FINDINGS, THE MANUFACTURER'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THE SUBJECT GRAFT CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. NO FURTHER ACTION IS DEEMED NECESSARY. THIS INCIDENT IS CONSIDERED CLOSED.