PROGENIX DBM PUTTY
Received Dec 20, 2010 · Event occurred Nov 1, 2010
Report 1030489-2010-01612 · MDR key 1933421
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor Danek IncModel number
NACatalog number
006010
Lot number
1391090029
Product problems
- Insufficient Device Problem Information
Patient
00044 YR
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HISTORY OF BACK AND RADICULAR SYMPTOMS, FAILING EXHAUSTIVE CONSERVATIVE MEASURES. THE PATIENT WAS DIAGNOSED WITH L5-S1 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT L4-L5 LAMINECTOMIES WITH L5-S1 BILATERAL OSTEOTOMIES AND DISCECTOMIES WITH INTERBODY FUSIONS. AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED AN INFECTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THE EVENT DATE IS UNKNOWN. 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.