InjuryESF
QUEST MEMBRANE
Received Nov 13, 2000 · Event occurred Nov 1, 2000
Report MW1020376 · MDR key 304423
Device
Generic name
Resorbable Membrane
Manufacturer
W L Gore & AssociatesModel number
NACatalog number
OQ2530
Lot number
MULTIPLE
Product problems
- Reaction
Patient
NO INFO
- Inflammation
- Tissue Damage
Narrative
Description of Event or Problem
SEVERAL CASES REVIEWED AND COMMON CORROLATION TO THIS MEMBRANE WHICH IS CAUSING AN AGGRESSIVE INFLAMMATORY RESPONSE; SINUS AUGMENTATION WITH BONE GRAFT CAUSING NONCLINICAL REACTION. THERE WAS SOME TENDERNESS THAT EXTENDED AND BECAME ACUTE WITH SEVERE GRANULATION AND DESTRUCTION OF TISSUE. BOTH OF THESE PTS HAD REOPERATION.