inforMED
InjuryNPK

MEMBRAGEL

Received Sep 14, 2011 · Event occurred Jul 7, 2011

Report 1222315-2011-00037 · MDR key 2251473

Device

Generic name

Barrier Membrane

Catalog number

070.101

Lot number

Z5927

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

75 YR

  • Fistula
  • Unspecified Infection

Narrative

Description of Event or Problem

CLINICIAN REPORTS THAT THERE WAS AN INFECTION, REVISION AND THE PT IS UNDER CONTROL AFTER SURGERY WITH MEMBRAGEL, 070.101 LOT Z5927. SURGERY ON (B)(6) 2011 WITH RIDGE AUGMENTATION WITH BONE CERAMIC AND MEMBRAGEL IN REGION 11/12. ON (B)(6) 2011, A FISTULA WAS DISCOVERED AND THERE WAS A REVISION. THE CLINICIAN REPORTS THAT THE BONE CERAMIC IS NOT AFFECTED AND THERE WAS NO LOSS OF MEMBRAGEL WHICH IS STILL IN SITU. THE PT IS UNDER CONTROL/TREATMENT. THE HEATING IS VERY DELICATE.

Additional Manufacturer Narrative

THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPEC.