InjuryNPK
MEMBRAGEL
Received Nov 19, 2010
Report 1222315-2010-00017 · MDR key 1910642
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
CLINICIAN REPORTS: INFECTION IN A SITE WHERE MEMBRAGEL WAS PLACED, 3 IMPLANTS PLACED AND 2 OF THE 3 IMPLANTS FAILED, INDICATION WAS SINUS AUGMENTATION, HAS NOT YET DETERMINED WHETHER THE ISSUE RELATES TO MEMBRAGEL, MEMBRAGEL WAS THE ONLY CHANGE IN HER TYPICAL PROCEDURE.