InjuryNPK
MEMBRAGEL
Received Oct 19, 2010 · Event occurred Aug 26, 2010
Report 1222315-2010-00015 · MDR key 1880291
Device
Product problems
- Insufficient Device Problem Information
Patient
40 YR
- Unspecified Infection
- Pain
- Swelling
Narrative
Description of Event or Problem
CLINICIAN REPORTS A GUIDED BONE REGENERATION (GBR) TREATMENT WAS CARRIED OUT ON (B)(6) 2010 ON AN EXTRACTION SOCKET WITH IMMEDIATE IMPLANT PLACEMENT TO FILL GAP. AT ONE MONTH F/U ON (B)(6) 2010, CLINICIAN REPORTS THAT THERE WAS SIGNIFICANT SWELLING IN VESTIBULE AND ANTIBIOTICS WAS ADMINISTERED. CLINICIAN REPORTS PAIN, SWELLING AND INFECTION. BOTH MEMBRANE AND IMPLANT ARE STILL STABLE.
Additional Manufacturer Narrative
MFR COMPLETED A REVIEW OF THE MFG RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.