PROGENIX DBM PUTTY
Received Dec 20, 2010 · Event occurred Nov 10, 2010
Report 1030489-2010-01613 · MDR key 1933449
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
006010
Lot number
1409090051
Product problems
- Insufficient Device Problem Information
Patient
00070 YR
- Abscess
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RECURRENT T12-L5 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT A REDO OF PRIOR T12-L5 LAMINECTOMIES, L1-L5 BILATERAL OSTEOTOMOIES AND DISCECTOMIES AND INTERBODY FUSIONS. AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH A WOUND INFECTION AND UNDERWENT AN ASPIRATION AND LAMINECTOMY FROM L1-L5 WITH WOUND ABCESS IN SUBCUTANEOUS AND SUBMUSCULAR WITH USE OF INTRAOPERATIVE FLUOROSCOPE.
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.