MEMBRAGEL

Additional Manufacturer Narrative

MEMBRAGEL, CATALOG #070.101 PACKAGE INSERT INSTRUCTIONS FOR USE STATES "TREATMENT OUTCOME IS DEPENDENT ON OPERATIVE TECHNIQUE AND PATIENT RESPONSE. AS WITH ANY SURGICAL PROCEDURE, INFECTION IS A RISK. USE STERILE INTRA-OPERATIVE TECHNIQUE. DO NOT USE AT INFECTED SITES. 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 SPECIFICATION.

Description of Event or Problem

A PATIENT RECEIVED AN EXTENSIVE RIDGE AUGMENTATION IN FDI SITES 45-47 USING AUTOGENOUS BONE, BONE SUBSTITUTE MATERIAL AND MEMBRANE MEMBRAGEL. EXACT DATE OF PROCEDURE IS NOT REPORTED. CLINICIAN REPORTED ON (B)(6) 2012 THAT THE ORIGINAL OP WAS IN (B)(6). CLINICIAN REPORTS THAT IN SPITE OF PROACTIVE COURSE OF ANTIBIOTICS AND OBSERVANCE OF POST-OPERATIVE MEASURES, THE PATIENT SUFFERED AN EXTENSIVE INFECTION OF THE SOFT TISSUE. THE DATE OF OCCURRENCE IS NOT REPORTED. INFECTION, PAIN, BLEEDING, FISTULA AND SWELLING IS REPORTED. THE PROSTHESIS WAS NOT INSTALLED. FURTHER OPERATIVE TREATMENTS WERE NECESSARY TO REMOVE THE AUGUMENTAT. DATES OF ADDITIONAL TREATMENTS NOT REPORTED. CLINICIAN REPORTED VIA TELEPHONE ON (B)(6) 2012 THAT THE PATIENT HAD A CHECK-UP ON (B)(6) 2012 AND EVERYTHING HAS HEALED WELL. THE IMPLANTS ARE STILL IN PLACE. WHEN THE IMPLANTS WERE UNCOVERED, THE REMAINS OF MEMBRAGEL WERE REMOVED. THE SOFT TISSUE IS WITHOUT PATHOLOGICAL FINDINGS.