PROGENIX DBM PUTTY
Received Dec 20, 2010 · Event occurred Sep 15, 2010
Report 1030489-2010-01611 · MDR key 1933443
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
00048 YR
- Purulent Discharge
- Unspecified Infection
- Necrosis
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PROGRESSIVE DEFORMITY WITH KYPHOSIS, SPINAL INSTABILITY, INCREASE OF LEFT LUMBAR LORDOSIS, L1 COMPRESSION FRACTURE AND LOOSENING OF THE SCREWS AT L1. THE PATIENT UNDERWENT REDO OF A PRIOR L2-S1 FUSION PLUS T9-S1 POSTERIOR INSTRUMENTATION, REMOVAL OF L1 PEDICLES SCREWS, REVISION OF INTERBODY FUSION L1-L2 WITH REVISION OF THE L1-L2 CAGE AND L1 KYPHOPLASTY. AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH A SUPERFICIAL WOUND INFECTION. THE INFECTION WAS INITIALLY MANAGED WITH INFECTIOUS DISEASE WITH ANTIBIOTICS AND DRESSING CHANGES. THE PATIENT WAS THEN ADMITTED TO NURSING HOME AND RETURNING WITH A WORSENING WOUND WITH 3 POINTS OF LEAKAGE OF SEROPURULENT MATERIAL. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE NECROTIC TISSUES. THERE WERE FOUR POINTS BREAKING ON THE SKIN WITH LEAKAGE OF SEROPURULENT MATERIAL. THE SKIN WAS OPENED WITH GOOD BORDERS OF THIS NECROTIC TISSUE UNTIL WE WENT INTO THE FASCIA. IN THE FASCIA, IT WAS NOTED THAT THERE WAS WORSENING OF THE NECROTIC TISSUE. OPENED ALL THE FASCIA, REMOVED ALL THE NECROTIC TISSUE FROM THE MUSCLES, AND THE SUBCUTANEOUS TISSUE WITH A KNIFE AND WITH CURETTES AND USED 6 LITERS OF SALINE WITH BACITRACIN.
Additional Manufacturer Narrative
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# 1385400076, LOT# 138540079, AND LOT# 138540075. 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.
Additional Manufacturer Narrative
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# 1385400073, 1385400076, LOT# 138540079, AND LOT# 138540075.