MEMBRAGEL

Description of Event or Problem

CLINICIAN REPORTS THAT A DENTAL IMPLANTATION WITH 2 THOMEN IMPLANTS IN SITES FDI 46 AND 47 WAS CARRIED OUT ON (B)(6) 2012. AT THE SAME TIME THE SITES WERE AUGMENTED USING STRAUMANN BONE CERAMIC 070.204 LOT T9017 AND MEMBRAGEL 070.101 LOT AY440. THERE WERE NO DIFFICULTIES DURING THE OP AND THE CLINICIAN WAS VERY SATISFIED WITH THE RESULTS. AT THE CHECK-UP APPOINTMENT ON (B)(6) 2012, THE PT REPORTS PAIN AND THAT THE SITE HAS BEEN SWOLLEN SINCE 1 DAY AFTER THE OP. THE CLINICIAN REPORTS THAT THERE WAS A WOUND DEHISCENCE AND THE WOUND WAS VERY SENSITIVE. PT REPORTS MUCH PAIN SINCE 3 DAYS, DALACIN C (ANTIBIOTIC) WAS PRESCRIBED. THE CLINICIAN REPORTS THAT THE PT CANCELED THE APPOINTMENT ON (B)(6) 2012 WHEN IT WAS INTENDED TO REMOVE THE SUTURES. THE PT STATED ON APPROX (B)(6) 2012, THAT THE REASON FOR THE CANCELLATION WAS THAT THE PAIN HAD BEEN TOO MUCH AND HAD LOST 3 KG IN WEIGHT SO HE WENT TO ANOTHER DENTIST WHO PRESCRIBED ANOTHER COURSE OF ANTIBIOTICS, STRONG PAINKILLERS AND APPEARS TO HAVE REMOVED EVERYTHING. EXACT DATE OF TREATMENT IS NOT KNOWN. PT WILL NOT GIVE ANY DETAILS ABOUT THE OTHER DENTIST. CLINICIAN CONTACTED THE PT ON (B)(6) 2012 AND THE PT REPORTS THAT THINGS ARE BETTER.

Additional Manufacturer Narrative

MEMBRAGEL, CATALOG # 070.101 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 INFECTED SITES." MEMBRAGEL, CATALOG # 070.101 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." THE MFR CARRIED OUT A REVIEW OF THE BATCH RECORD DOCUMENTATION AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPEC.