MEMBRAGEL

Description of Event or Problem

CLINICIAN REPORTS THAT S SINUS LIFT PROCEDURE IN SITE (B)(6) WAS CARRIED OUT ON (B)(6) 2012, USING MEMBRAGEL AND BONE CERAMIC. ANTIBIOTIC DALACIN WAS PRESCRIBED. THE SUTURES WERE REMOVED ON (B)(6) 2012, WITHOUT ANY PROBLEMS. ON (B)(6) 2012 THERE WAS A FISTULA WITH LARGE ABSCESS IN THE VESTIBULAR AREA. MATERIAL (BONE CERAMIC AND MEMBRAGEL) WERE SQUEEZED OUT THROUGH THE FISTULA. TREATMENT WITH ANTIBIOTIC DALACIN. THERE WAS A SURGICAL CHECK UP ON (B)(6) 2012. THE REMAINING MEMBRAGEL WAS REMOVED. THE INTRASINAL TRANSPLANT REMAINED IN SITU AS IT WAS NOT CONTAMINATED. TREATMENT WITH ANTIBIOTIC DALACIN. THE SUTURES WERE REMOVED ON (B)(6) 2012. THERE WAS STILL A (BLACK) FISTULA. THERE WAS A CHECK UP ON (B)(6) 2012. THERE WAS STILL A FISTULA WHICH WAS THICK AND SMELLED BAD.

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 MANUFACTURER CARRIED OUT A REVIEW OF THE BATCH RECORD DOCUMENTATION AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.