MEMBRAGEL
Received Jul 20, 2010 · Event occurred May 28, 2010
Report 1222315-2010-00009 · MDR key 1765431
Device
Product problems
- Extrusion
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
HORIZONTAL AND VERTICAL DEFECT TREATED ON (B)(6) 2010 WITH BONE GRAFT MATERIAL (STRAUMANN BONE CERAMIC) AND MEMBRAGEL. ONE MONTH AFTER THE SURGERY A MEMBRANE EXPOSURE OF MORE THAN 3MM APPEARED TOGETHER WITH INFECTION. THIS EXPOSURE WAS FOLLOWED UP FOR A PERIOD OF TIME AND IT GOT WORSE. SECOND PHASE DUE TO WORSENING: REMOVAL OF THE MATERIAL AND RE-TREATMENT.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THE PRODUCT WAS RELEASE 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."