InjuryNPK
MEMBRAGEL
Received Apr 12, 2011 · Event occurred Apr 7, 2011
Report 1222315-2011-00001 · MDR key 2097783
Device
Product problems
- Failure To Adhere Or Bond
Patient
65 YR
- Fistula
Narrative
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECS.
Description of Event or Problem
CLINICIAN REPORTS "PT HAD A FISTULA AFTER 3 MONTHS. AFTER RE-ENTRY NO MEMBRANE IS VISIBLE. THE BONE REPLACEMENT MATERIAL IS STILL VERY SOFT. PT IS WELL."