InjuryNPK
STRAUMANN BONE CERAMIC
Received Jun 23, 2011 · Event occurred Nov 9, 2010
Report 1222315-2011-00010 · MDR key 2143097
Device
Generic name
Synthetic Bone Grafting Material
Manufacturer
Biora AbCatalog number
070.204
Lot number
T9017
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Fistula
Narrative
Description of Event or Problem
ON (B)(6) 2010, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Y9146 AND STRAUMANN BONE CERAMIC, 0.5-1.0, 0.5G, ARTICLE 070.204 BATCH Y9017. CLINICIAN REPORTS ON (B)(6) 2010 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT HAD FISTULA.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.