InjuryNPK
MEMBRAGEL
Received Sep 16, 2011 · Event occurred May 29, 2011
Report 1222315-2011-00039 · MDR key 2256887
Device
Product problems
- Degraded
- Material Protrusion/Extrusion
Patient
66 YR
- Unspecified Infection
Narrative
Description of Event or Problem
CLINICIAN REPORTS SURGERY ON (B)(6) 2011 IN REGION 36 USING MEMBRAGEL AND BONE CERAMIC. ON (B)(6) 2011, THERE WAS LOSS OF MEMBRAGEL. BONE CERAMIC IS NOT AFFECTED. THE MEMBRANE WAS EXPOSED, DEGRADATION MATERIAL WAS EXUDED. INFECTION WAS SUCCESSFULLY TREATED.
Additional Manufacturer Narrative
THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION.