MAGNIFUSE (GRAFTON II EDBM)

Description of Event or Problem

THE PT RECEIVED A BONE VOID FILLER ALLOGRAFT DURING AN ANTERIOR LUMBAR INTERBODY FUSION, AND APPROX TWO WEEKS LATER DEVELOPED A POST-OPERATIVE INFECTION.

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. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE BY OSTEOTECH TO OBTAIN ADD'L DETAILS REGARDING THE PT'S TREATMENT AND PROGRESS. THE MFG RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED AND INDICATED THAT THE GRAFT WAS MANUFACTURED PER PROCEDURE AND MET ALL SPECIFICATIONS AND RELEASED CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE PROCESSING OF THE SUBJECT LOT OF PRODUCT. THERE WERE NO DEVIATIONS, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH MFG. FINAL PRODUCT STERILITY RESULTS WERE NEGATIVE (NO GROWTH), AND ENVIRONMENTAL MONITORING RESULTS WERE ACCEPTABLE. A COMPREHENSIVE REVIEW OF THE DONOR RECORDS BY OSTEOTECH'S MEDICAL DIRECTOR CONCLUDED THAT THE SUBJECT DONOR HAD BEEN APPROPRIATELY SCREENED AND TESTED IN ACCORDANCE WITH OSTEOTECH'S DONOR SUITABILITY CRITERIA. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH (COMMUNITY TISSUE SERVICES) WAS NOTIFIED OF THIS REPORT; NEITHER THEY, NOT OSTEOTECH, HAS RECEIVED ANY ADD'L REPORTS OF INFECTION INVOLVING TISSUES PROCURED OR PRODUCTS MANUFACTURED FROM THE SUBJECT DONOR. BASED ON THESE FINDINGS AND THE INFO PROVIDED, OSTEOTECH'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT THE SUBJECT GRAFT WAS THE CAUSE OF THE PT'S POST-OPERATIVE INFECTION. NO FURTHER ACTION IS REQUIRED AND THIS INVESTIGATION IS CONSIDERED CLOSED.