InjuryNPK
MEMBRAGEL
Received Apr 16, 2010
Report 1222315-2010-00006 · MDR key 1661755
Device
Product problems
- Extrusion
Patient
Not reported
- Unspecified Infection
- Impaired Healing
Narrative
Description of Event or Problem
CLINICIAN REPORTS, THE MEMBRAGEL WAS USED AT THE TIME OF AN IMPLANT PLACEMENT WITH ALLOGRAFT IN A BUCCAL DEHISCENCE WITH FENESTRATION. CLINICIAN REPORTED THAT THE SITE DID NOT HEAL WELL AND INFECTION OCCURRED WITH PIECES OF THE MEMBRAGEL COMING OUT.
Additional Manufacturer Narrative
MANUFACTURER COMPLETED A REVIEW OF THE MANUFACTURING RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.