InjuryNPK
MEMBRAGEL
Received May 3, 2011 · Event occurred Dec 22, 2010
Report 1222315-2011-00002 · MDR key 2092569
Device
Product problems
- Device Or Device Fragments Location Unknown
Patient
Not reported
- Abscess
- Unspecified Infection
- Perforation
Narrative
Description of Event or Problem
USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101 BATCH Y6364 AND STRAUMANN BONE CERAMIC, 0.5-1.0, 0.5G, ARTICLE 070.204 BATCH Y8042. CLINICIAN REPORTS APPROX 3 WEEKS AFTER USING MEMBRAGEL THE PT HAD PUS. THE MEMBRAGEL MADE A PERFORATION THROUGH THE BUCCAL MUCUSA. THE ENTIRE MATERIAL INCLUDING THE BONE CERAMIC HAS TO BE REMOVED. THE IMPLANTS ARE STILL IN SITU. THE CLINICIAN REPORTS THAT THE PT IS WELL. MEMBRANE AND BONE CERAMIC WERE LOST DUE TO INFECTION. IMPLANT IS NOW WITHOUT BONE CERAMIC IN SITU - VERY LIKELY IT WILL OSSEOINTEGRATE.