MEMBRAGEL

Description of Event or Problem

IMPLANTATION OF A DENTAL IMPLANT WAS CARRIED OUT ON (B)(6), 2011 IN REGIO 23 WITH CONCURRENT AUGMENTATION USING BONE CERAMIC 070.204 LOT Z0666 AND MEMBRAGEL 070.101 AL077. DAFALGAN, (B)(6) AND DOXYLINE WERE PRESCRIBED. CLINICIAN REPORTS ON (B)(6), 2011 THERE WAS A DEHISCENCE ABOVE THE IMPLANT. THE MEMBRAGEL WAS SWOLLEN AND EXPOSED. THE MEMBRANE WAS SHORTENED AND NEWLY SUTURED. ON (B)(6), 2012 THERE WAS A VESTIBULAR SUTURE DEHISCENCE. (B)(6) WERE USED. ON (B)(6), 2011 IT IS REPORTED THAT IT WAS BETTER BUT THERE WAS STILL AN OPENING. (B)(6) USED. ON (B)(6), 2011 THERE WAS AN APICAL DEHISCENCE IN REGION 24. (B)(6) USED. ON (B)(6), 2011 THERE WAS AN APICAL SUTURE DEHISCENCE 1MM IN DIAMETER IN REGION 24. THE BONE/MEMBRAGEL WERE VISIBLE. PT REPORTS PAIN. THE SUTURES WERE EXPLANTED IN 10 DAYS. ON (B)(6), 2011, THE WOUND HAD HEALED BUT THE EDGES WERE STILL RED. (B)(6) PRESCRIBED. REMOVAL OF THE SUTURES. ON (B)(6), 2011 THE IMPLANT IN REGION 23 WAS UNCOVERED. THERE WAS BUCCAL SWELLING. A RELEASE INCISION WAS MADE. THE BONE CERAMIC AND MEMBRAGEL WERE REMOVED.

Additional Manufacturer Narrative

CATALOG# 070.101, MEMBRAGEL, PACKAGE INSERT INSTRUCTIONS FOR USE STATE "TREATMENT OUTCOME IS DEPENDENT ON OPERATIVE TECHNIQUE AND PT RESPONSE. AS WITH ANY SURGICAL PROCEDURE, INFECTION IS A RISK. USE STERILE INTRA-OPERATIVE TECHNIQUE. DO NOT USE AT INFECTION SITES." CATALOG# 070.101, MEMBRAGEL, PACKAGE INSERT INSTRUCTIONS FOR USE STATE "THE FOLLOWING COMPLICATIONS ARE COMMON WITH THE SURGICAL INTERVENTION WITH BARRIER MEMBRANES AND THEREFORE MAY NOT BE TOTALLY EXCLUDED: SOFT TISSUE DEHISCENCE, HEMATOMA, PAIN, INFLAMMATION, INCREASED SENSITIVITY AND REDNESS."