GRAFTON MATRIX PLF
Received Mar 14, 2012 · Event occurred Dec 28, 2011
Report 2246640-2012-00004 · MDR key 2496268
Device
Generic name
Demineralized Bone Matrix Allograft
Manufacturer
Osteotech, IncModel number
2.5 X 5CMCatalog number
A42210
Lot number
OTSLN0812224037
Product problems
- Migration or Expulsion of Device
Patient
72 YR
- No Code Available
Narrative
Description of Event or Problem
DURING A 2-LEVEL FUSION (L2-L4), THE SURGEON PLACED DBM BONE VOID FILLER INSIDE THE PEEK CAGE AS WELL AS IN THE DISC SPACE ANTERIOR TO THE CAGE. AT TWO WEEKS POST-OP, THE CAGE HAD MIGRATED POSTERIORLY. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE CAGE WAS REMOVED AND REPLACED ON THE CONTRA-LATERAL SIDE WITH A SMALLER SIZE CAGE. THE DBM GRAFT MATERIAL WAS REMOVED FROM THE DISC SPACE.
Additional Manufacturer Narrative
MFG RECORDS WERE REVIEWED AND INDICATED THAT THE SUBJECT LOT OF PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE MFG OF THE PRODUCT, AND THERE WERE NO IRREGULARITIES ASSOCIATED WITH MFG. NEITHER THE DEVICE NOR ANY FILMS OF APPLICABLE IMAGING STUDIES WERE PROVIDED BY THE INITIAL RPTR. THE DEFINITIVE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.