MEMBRAGEL
Received Jul 20, 2010 · Event occurred May 19, 2010
Report 1222315-2010-00010 · MDR key 1765445
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS. THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT STATE "AS WITH ANY SURGICAL PROCEDURE, INFECTION IS A RISK." AS WELL AS "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."
Description of Event or Problem
HORIZONTAL AND VERTICAL DEFECT TREATED WITH MEMBRAGEL BONE GRAFT MATERIAL (STRAUMANN BONE CERAMIC) ON (B)(6) 2010. ON REMOVAL OF THE SUTURES PATIENT HAD A MEMBRANE EXPOSURE OF MORE THAN 2 MM TOGETHER WITH INFECTION. COMPLETE REMOVAL OF THE MATERIAL, COLLAGEN SPONGE AND ANTIBIOTICS AND ANALGESICS. THE ADVERSE REACTION HAS RESOLVED.