PLEXUR M

Description of Event or Problem

PATIENT IS A FEMALE WITH A LEFT LATERAL TIBIAL PLATEAU FRACTURE. IN 2009, DR PLACED A DEPUY MOLDABLE PLATE AND SCREWS AND FILLED THE FRACTURE GAP WITH PLEXUR M. DUE TO PATIENT'S ADVANCED AGE, DR STARTED HER ON EARLY WEIGHT BEARING TO MOBILIZE HER QUICKLY. TWO MONTHS POST-OPERATIVELY, THE PATIENT WAS DOING WELL, BUT BEGAN TO HAVE SOME WOUND DRAINAGE. DR RE-OPERATED, EXPLANTED THE GRAFT MATERIAL AND FILLED THE VOID WITH BONE CHIPS. CULTURES OF THE PLEXUR M MATERIAL WERE POSITIVE FOR PROPIONIBACTERIUM ACNES. TWO MONTHS LATER, IN A TELEPHONE CONVERSATION WITH OSTEOTECH'S MEDICAL DIRECTOR, DR REPORTED THAT THE PATIENT IS RECOVERING AND IMPROVING.

Additional Manufacturer Narrative

AN INVESTIGATION WAS UNDERTAKEN TO ASSESS THE CONTRIBUTION OF THE SUBJECT PLEXUR M GRAFT TO THE PATIENT'S POST-OPERATIVE PROPIONIBACTERIUM ACNES INFECTION. A REVIEW OF ALL RELEVANT DONOR TISSUE, MANUFACTURING AND TESTING RECORDS WAS PERFORMED. EVALUATION RESULTS: THE INVESTIGATION CONCLUDED WITH NO POSSIBLE ROOT CAUSE FOR THE RELEASE OF THIS PRODUCT AS A NON-STERILE PRODUCT. ALL DONOR AND BATCH PROCESSING RECORDS INDICATE THAT THE SUBJECT GRAFT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL OSTEOTECH SPECIFICATIONS. IN-PROCESS ENVIRONMENTAL MONITORING RESULTS COMPLIED. ENDOTOXIN TESTING RESULTS COMPLIED. ALL PROCESS RECORDS FOR TERMINAL STERILIZATION, CLEANING PACKAGING AND SHIPPING COMPLIED. BASED ON THE DOSE LEVEL OF GAMMA IRRADIATION APPLIED TO PLEXUR M AND THE ENDOTOXIN TEST RESULT, THE PLEXUR M MANUFACTURING PROCESS IS EFFECTIVE IN DESTROYING ALL ORGANISMS IF PRESENT, INCLUDING P. ACNES. IN SUMMARY, THE INVESTIGATION CONCLUDED THAT, WITH A HIGH DEGREE OF CONFIDENCE, THE SUBJECT GRAFT WAS PROCESSED, TESTED, PACKAGED, TERMINALLY STERILIZED WITH GAMMA IRRADIATION, RELEASED AND DELIVERED STERILE AS LABELED. THIS INVESTIGATION IS CONSIDERED CLOSED.