MEMBRAGEL

Description of Event or Problem

BONE AUGMENTATION WITHOUT IMPLANTATION ON (B)(6) 2010 REGIO 44. BONE CERAMIC 070.203 LOT Y8039 AND MEMBRAGEL 070.101, LOT Y6371 PERIO CUT, AREA STRESS-FREE. ON (B)(6) 2010, PATIENT HAS SWELLING IN AREA. ON (B)(6) 2010, LITTLE PAIN BUT SWELLING, WOUND HEALING WELL WITHOUT DEHISCENCE, SUTURE REMOVAL. ON (B)(6) 2010, FISTULA, DEHISCENCE, LIQUID EXUDING, POINT-SHAPED DEHISCENCE, SOME SWELLING, PUS, PAIN UNDER PRESSURE NACL-SOLUTION RINSED VIA DEHISCENCE, REST OF WOUND IN ICE. ON (B)(6) 1010, BETTER, LESS LIQUID OUT OF DEHISCENCE, RINSING. ON (B)(6) 2010, STILL UNCLEAR RINSING. ON (B)(6) 2010, RINSING, DEHISCENCE STILL OPEN, LIQUID SECRETION DURING RINSING, RINSING WITH NACL. ON (B)(6) 2010, REMOVAL OF COMPLETE CONSTRUCTION, RINSING WITH NACL. ON (B)(6) 2011, PERFORATION OF CORTICALIS, AUGMENTATION USING BIO OSS AND BIO GIDE (GEISTLICH). ON (B)(B) 2011, NICE WOUND HEALING, NO INFLAMMATION, REMOVAL OF SUTURE. ON (B)(6) 2011, NO SWELLING OR REDNESS. ON (B)(6) 2011, MOUTH HYGIENE NOT OPTIMAL, A LOT OF PLAQUE. ON (B)(6) 2011, IMPLANTATION REGIO 44 WITH IMPLANT 033.52S LOT AP054. ON (B)(6) 2011, WELL AND NICE WOUND HEALING, OSSTELL MEASUREMENT GOOD.

Additional Manufacturer Narrative

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