PEPGEN P-15 PUTTY

Description of Event or Problem

INFECTION DEVELOPED AND PRIMARY STABILITY WAS NOT ACHIEVED AFTER CONCURRENT PLACEMENT OF PEPGEN P-15 PUTTY BONE GRAFTING MATERIAL AND AN IMPLANT. ALSO, THE IMPLANT AND GRAFT LIKELY DID NOT OSSEOINTEGRATE SECONDARY TO THE INFECTION AND LACK OF PRIMARY STABILITY; IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT. AS A RESULT, IT CAN BE PRESUMED THAT ANOTHER SURGICAL PROCEDURE WOULD BE NECESSARY TO ACHIEVE THE DESIRED RESULTS AND PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE THAT WOULD NOT BE TRIVIAL.

Additional Manufacturer Narrative

FAILURE TO OSSEONITEGRATE AND DEVELOPMENT OF INFECTIONS ARE INHERENT RISK OF THE PROCEDURE KNOWN TO DOCTOR AND PT BEFORE THE PROCEDURE IS INITIATED ,AND ARE DEPENDENT ON MANY FACTORS INCLUDING THE PT' AGE, SEX,HEALTH, AND SOCIAL HISTORY, THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, AND GRAFT PLACEMENT TECHNIQUE. THOUGH PEPGEN WILL REMODEL TO BONE AT A SIMILAR RATE AS NATURAL BONE IN A PT, IT IS IMPOSSIBLE TO DETERMINE THE SPECIFIC RESORPTION RATE OF ANY BONE GRAFTING MATERIAL; MATERIAL PLACED IN AN AREA OF LOW VASCULARITY AND LITTLE OSTEOGENIC POTENTIAL WILL TAKE MUCH LONGER TO REMODEL TO BONE THAN IF PLACED IN A MORE ACTIVE SITE. CONSIDERING THIS AND THE AVAILABLE INFORMATION, THIS EVENT DOES NOT APPEAR TO BE A RESULT OF A MALFUNCTION OF THE DEVICE. THE IMPLANT LOSE WILL BE REPORTED VIA ASR. THE LOT NUMBER WAS PROVIDED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. PLEASE NOTE THAT THIS EVENT AND THE EVENT DOCUMENTED UNDER REPORT NUMBER 172141-2006-00248 INVOLVE THE SAME PT.