GRAFTON PLUS DBM PASTE

Description of Event or Problem

IT WAS REPORTED VIA VOLUNTARY MEDWATCH THAT A PT HAD DEVELOPED A SURGICAL SITE INFECTION TWO DAYS AFTER IMPLANTATION WITH AN ALLOGRAFT BONE VOID FILLER. THE PT REQUIRED A REVISION SURGERY.

Additional Manufacturer Narrative

THIS MEDWATCH FORM WAS COMPLETED USING THE INFO PROVIDED ON THE MAUDE EVENT REPORT RECEIVED FROM CDRH. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED ON THE REPORT. THE INITIAL REPORTER WAS NOT IDENTIFIED, THEREFORE NO ADD'L INFO COULD BE OBTAINED BY OSTEOTECH. THIS INCIDENT WAS REPORTED AFTER A VOLUNTARY RECALL LETTER, REQUESTING THAT HOSPITALS REVIEW PAST PT INJURIES INVOLVING RECALLED PRODUCT, WAS SENT OUT BY MEDTRONIC/OSTEOTECH. THIS INCIDENT WAS NOT REPORTED AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. OSTEOTECH'S MEDICAL DIRECTOR HAS CONFIRMED THAT THE SUBJECT DONOR WAS APPROPRIATELY SCREENED AND TESTED IN ACCORDANCE WITH DONOR SUITABILITY CRITERIA. ALL SEROLOGY RESULTS COMPLIED. MFG RECORDS WERE REVIEWED AND INDICATED THAT THE SUBJECT GRAFT WAS MANUFACTURED PER PROCEDURE AND MET ALL SPECS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE PROCESSING OF THE PRODUCT, AND THERE WERE NO DEVIATIONS, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH MFG. FINAL PRODUCT STERILITY RESULTS WERE NEGATIVE (NO GROWTH), AND ENVIRONMENTAL MONITORING RESULTS COMPLIED. NO ADD'L REPORTS OF INFECTION HAVE BEEN RECEIVED BY OSTEOTECH INVOLVING THIS DONOR TISSUE, NOR BY THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE TISSUE TO OSTEOTECH. OSTEOTECH'S MEDICAL RECORD DIRECTOR HAS OCCLUDED THAT THERE IS NO MEDICAL EVIDENCE LINKING THE GRAFT TO THE PT'S INFECTION. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.