MEMBRAGEL

Description of Event or Problem

BONE AUGMENTATION WITHOUT IMPLANTATION PROCEDURE CARRIED OUT ON (B)(6) 2011: SURGERY REGIO 21 WITH BONECERAMIC AND MEMBRAGEL. BONE DEFECT LARGE, ALSO WITH SIDE DEFECTS SO IMPLANT CAN NOT BE PLACED. PERFORATION APPLIED / ALVEOLE FILLED WITH A LITTLE OVERFILL / MEMBRAGEL PLACED CLEANLY / BONE WAS DRY DURING PLACEMENT / PERIO-CUT TO 23 / AREA WITH OVERRUN STRESS-FREE. (B)(6) 2011 SOME PAIN AND SWELLING / WOUND HEALING GOOD / PT DID NOT SMOKE, ONLY SMOKING HASH. (B)(6) 2011 NO PAIN / PT DID NOT SMOKE, ONLY SMOKING HASH / NO SWELLING / NO DEHISCENCE. (B)(6) 2011 UNDER PRESSURE A LOT OF PUS. (B)(6) 2011 STILL UNDER PRESSURE A LOT OF PUS MIXED WITH GRANULATE / REMOVAL OF CONSTRUCTION IS PLANNED. (B)(6) 2011 REMOVAL OF BONE AUGMENTATION / RECOMMENDATION: ADHESIVE BRIDGE. (B)(6) 2011 PT HAD STRONG PAIN. (B)(6) 2011 WOUND HEALING WELL / REMOVAL OF SUTURE. (B)(6) 2011 EVERYTHING IS GOOD / UNDER PRESSURE LESS PUS OUT OF ALVEOLE / RINSING WITH NACL-SOLUTION.

Additional Manufacturer Narrative

THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION.