InjuryNPK
STRAUMANN BONE CERAMIC
Received Jun 23, 2011 · Event occurred Jan 21, 2011
Report 1222315-2011-00011 · MDR key 2143098
Device
Generic name
Synthetic Bone Grafting Material
Manufacturer
Biora AbCatalog number
070.203
Lot number
Y0263
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fistula
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem
ON (B)(6) 2011, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Z8930 AND STRAUMANN BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203, BATCH Y0263. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT HAD INFECTION AND FISTULA.