InjuryNPK
MEMBRAGEL
Received Sep 14, 2011 · Event occurred Aug 15, 2011
Report 1222315-2011-00036 · MDR key 2251463
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Pain
- Swelling
Narrative
Description of Event or Problem
IMPLANTATION OF IMPLANT ARTICLE NUMBER 033.653S, LOT AK316 WITH RIDGE AUGMENTATION USING BIOOSS (B)(4), LOT 11033 AND MEMBRAGEL 0.8 ML LOT AN688 ON (B)(6), 2011. ONLY THE AUGMENTATION MATERIAL WAS REMOVED ON (B)(6), 2011. THE IMPLANT WAS STABLE. CLINICIAN REPORTS THAT THE PT HAD PAIN AND SWELLING INFECTION.
Additional Manufacturer Narrative
THE BATCH RECORD REVIEW HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS MFG AND RELEASED ACCORDING TO SPECS.