MEMBRAGEL
Received Sep 17, 2010 · Event occurred Aug 10, 2010
Report 1222315-2010-00012 · MDR key 1845963
Device
Product problems
- Detachment Of Device Component
Patient
33 YR
- Fistula
- Unspecified Infection
Narrative
Description of Event or Problem
CLINICIAN REPORTS THAT MEMBRAGEL TOGETHER WITH GRAFTING MATERIAL WAS USED IN A LATERAL RIDGE AUGMENTATION PROCEDURE ON (B)(6)2010 TO TREAT A COMBINED VERTICAL AND HORIZONTAL DEFECT. PT PRESENTED WITH AN INFECTION AROUND IMPLANT SITE ON (B)(6)2010. ANTIBIOTICS WERE PRESCRIBED FOR 1 WEEK. THE CLINICIAN DRAINED THE INFECTION AND THE PT MENTIONED THAT A SMALL PIECE OF SOMETHING HAD COME OUT OF SITE #12. ALTHOUGH A SMALL FISTULA IS PRESENT IN THE GRAFTING MATERIAL AND MEMBRAGEL REMAINED IN PLACE.
Additional Manufacturer Narrative
MANUFACTURER COMPLETED REVIEW OF THE MANUFACTURING RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.