GRAFTON DBM PUTTY, 1.0CC

Description of Event or Problem

IT WAS REPORTED VIA MAUDE EVENT REPORT THAT A PT HAD RECEIVED A BONE VOID FILLER ALLOGRAFT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE FOR A NON-UNION OF THE LEFT ULNA. THE PT WAS READMITTED TO THE HOSP APPROX 8 WEEKS LATER FOR AN INCISION AND DRAINAGE (I AND D) OF THE LEFT ULNA, "WHERE A COPIOUS AMOUNT OF GRAY FLUID WAS EVACUATED AS DOCUMENTED BY SURGEON." NO ADD'L PT OR CLINICAL INFO WAS PROVIDED.

Additional Manufacturer Narrative

THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO RECEIVED ON THE MAUDE EVENT REPORT. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED ON THE REPORT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADD'L PT INFO FROM THE LISTED INITIAL REPORTER, THOUGH NONE WAS PROVIDED. THIS ADVERSE EVENT WAS REPORTED FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PT INJURIES REQUESTED BY OSTEOTECH/MEDTRONIC AS PART OF THE ABOVE REFERENCED VOLUNTARY RECALL. THIS EVENT WAS NOT REPORTED TO THE COMPANY AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. THE MFG AND LABORATORY TESTING RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MFG ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECS AND RELEASE CRITERIA. DONOR SUITABILITY RECORDS WERE REVIEWED AND THE DONOR WAS CONFIRMED TO BE ELIGIBLE FOR TRANSPLANTATION. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH WAS NOTIFIED OF THIS INCIDENT, AND NO ADD'L REPORTS OF THIS NATURE HAVE BEEN RECEIVED BY THE RECOVERY ORGANIZATION, OR BY OSTEOTECH, INVOLVING THIS DONOR TISSUE. BASED ON THESE FINDINGS, OSTEOTECH'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THE GRAFT WAS THE PROXIMATE CAUSE OF THE ADVERSE EVENT. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.