PEPGEN P-15

Description of Event or Problem

ONO OSSEOCINTEGRATION WAS ACHIEVEDIN A SITE APPROX SIX MONTHS AFTER CONCURRENT PLACEMENT OF DBX PUTTY, PEPGEN P-15 BONE GRAFTING MATERIAL, AND AN IMPLANT. IT WAS ALSO STATED THAT CLINICAL SOFT TISSUE DEHISCENCE EXPOSING THE IMPLANT, PROGRESSIVE BONE LOSS, AND PERI-IMPLANTITIS RESULTED; 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 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 OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DR AND PT BEFORE THE PROCEDURE IS INITIATED AND IS DEPENDANT ON MANY FACTORS INCLUDING THE PT'S AGE, SEX, HEALTH, AND SOCIAL HISTORY, THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, OCCURRENCE OF SITE PREPARATION TRAUMA (HEAT OR PRESSURE), PRIMARY STABILITY OF THE IMPLANT, 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 INFO, THIS EVENT DOES NOT APPEAR TO BE A RESULT OF A MALFUNCTION OF THE DEVICE. THE IMPLANT LOSS WILL BE REPORTED VIA ASR. THE LOT NUMBER WAS PROVIDED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUMBITTED AS THEY BECOME AVAILABLE. PLEASE NOTE THAT THIS EVENT AND THE EVENT DOCUMENTED UNDER REPORT NUMBER 1721411-2006-00290 INVOLVE THE SAME PT. IT APPEARS THE IMPLANT LOST IN THIS EVENT WAS REPLACED BY THE IMPLANT ASSOCIATED WITH THE AFOREMENTIONED EVENT. [PMA/510(K)#:P990033].