GRAFTON DBM PUTTY

Description of Event or Problem

DENTIST REPORTED THAT THE PT WAS IMPLANTED WITH ALLOGRAFT BONE VOID FILLER FOLLOWING AN EXTRACTION OF TOOTH #18 AND PLACEMENT OF A DENTAL IMPLANT IN #18. THE DENTIST STATED THE PT DEVELOPED A POST-OP INFECTION "IMMEDIATELY FOLLOWING PROCEDURE," AND WAS STARTED ON ANTIBIOTIC THERAPY. (B)(6) WEEKS POST-OP, THE PT CONTINUED TO BE "SWOLLEN AND UNCOMFORTABLE" AND WAS REFERRED TO AN ORAL SURGEON. THE PT'S CURRENT STATUS WAS DESCRIBED AS "HEALING WITH MODERATE BONY DEFECT."

Additional Manufacturer Narrative

THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. THIS ADVERSE EVENT WAS REPORTED BY THE DENTIST FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PT INJURIES REQUESTED BY THE COMPANY AS PART OF THE ABOVE REFERENCED VOLUNTARY RECALL, AND WAS NOT REPORTED TO THE COMPANY AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. THE MFG AND LAB TESTING RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. DONOR SUITABILITY RECORDS WERE REVIEWED BY OSTEOTECH'S MEDICAL DIRECTOR, AND THE DONOR MET ALL ELIGIBILITY REQUIREMENTS; ALL SEROLOGY RESULTS WERE COMPLIANT. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH, WAS NOTIFIED OF THIS INCIDENT, AND NO ADD'L REPORTS OF INFECTION HAVE BEEN RECEIVED BY THE RECOVERY ORGANIZATION, NOR BY THE OSTEOTECH INVOLVING THIS DONOR TISSUE. BASED ON THESE FINDINGS, OSTEOTECH'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THIS BONE VOID FILLER WAS THE PROXIMATE CAUSE OF THE PT'S INFECTION. NO FURTHER ACTION IS REQUIRED AND THIS INCIDENT IS CONSIDERED CLOSED.