InjuryNPK
MEMBRAGEL
Received Aug 22, 2011 · Event occurred Jul 29, 2011
Report 1222315-2011-00032 · MDR key 2227040
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Fistula
Narrative
Description of Event or Problem
ON (B)(6) 2011 SURGERY WITH USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Z5930 AND STRAUMANN BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203, BATCH Y8040. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND BONE CERAMIC THE PATIENT HAD LOSS OF MEMBRAGEL AND FISTULA DISCOVERED ON (B)(6) 2011. PROVISIONAL BRIDGE WAS INSERTED ON (B)(6) 2011.