STRAUMANN BONE CERAMIC
Received Jul 15, 2011 · Event occurred Dec 20, 2010
Report 1222315-2011-00031 · MDR key 2169516
Device
Generic name
Synthetic Bone Grafting Material
Manufacturer
Inst Straumann, AgCatalog number
070.204
Lot number
Y0113
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Abscess
- Fistula
- Unspecified Infection
- Swelling
Narrative
Description of Event or Problem
CLINICIAN REPORTS APPROX 6 WEEKS AFTER A BONE BLOCK TRANSPLANT TREATMENT USING MEBRAGEL AND STRAUMANN BONE CERAMIC ABSCESSES APPEARED. THE CLINICIAN NOTED THAT IT APPEARED TO BE HEALING BUT NOW THE ABCESSES ARE RETURNING. AUGMENTATION WITH AUTOLOGIC BONE (MICROSS) AND BONE CERAMIC. ON (B)(6) 2011 CLINICIAN IDENTIFIED TO STRAUMANN THAT THE PRODUCT INVOLVED IS ARTICLE 070.101, MEMBRAGEL, 0.8 ML, LOT Y0113 AND ARTICLE 070.204, STRAUMANN BONE CERAMIC, 0.5-1.0MM, 0.5G, LOT Y0113. ON (B)(6) 2010 SWELLING AND FISTULA OBSERVED. INFECTION TREATED WITH DALACIN AND CHC.
Additional Manufacturer Narrative
REVIEW OF LOT Y0113 BATCH RECORD INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECS. A REVIEW OF THE MFR PRODUCT COMPLAINT DATABASE SHOW THAT NO FURTHER COMPLAINTS WHERE INFECTION (FISTULA, ABSCESSES) HAVE BEEN REPORTED, HAVE BEEN RECEIVED BY THE MFR WITH LOT NUMBER Y0113. CLINICIAN SUPPLIED ADD'L INFO CONCERNING EVENT PROVIDED TO MFR ON 6/20/2011.