PROGENIX DBM PUTTY
Received Dec 20, 2010 · Event occurred Oct 28, 2010
Report 1030489-2010-01614 · MDR key 1933427
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
006010
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
00050 YR
- Inflammation
Narrative
Additional Manufacturer Narrative
THE EVENT DATE IS UNKNOWN. THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT# 1416540084 AND LOT# 1416540087. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATION.
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 UNDERWENT LUMBAR SPINAL FUSION SURGERY USING DBM PUTTY. TWO DAYS POST-OP, THE PATIENT RETURNED TO THE OR FOR A SUSPECTED INFECTION. UPON OPENING AND EXAMINING THE WOUND, THE SURGEON FOUND INFLAMED TISSUE, BUT NO INFECTION.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.