PEPGEN P-15 PUTTY

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 PUTTY WAS PLACED PRE-OPERATIVELY IN THE LEFT ANTERIOR MAXILLA WITH EXCELLENT/FAIR ORAL HYGIENE AND REPORTED BONE QUALITY TYPE II/III. THE OSTEOTOMY WAS PREPARED VIA DRILLING, BONE CONDENSING, AND THREAD CUTTING, AND HEALING WAS SUBGINGIVAL; THE TIME THE GRAPH WAS IN PLACE PRIOR TO PLACEMENT OF THE IMPLANT IS UNKNOWN. THE SITE HAD PROGRESSIVE BONE LOSS AND THE IMPLANT DID NOT OSSEOINTEGRATE AND WAS EXPLANTED APPROX 3.5 MONTHS POST-PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT.