PROGENIX DBM PUTTY
Received Sep 30, 2010 · Event occurred Aug 3, 2010
Report 1030489-2010-01273 · MDR key 1858751
Device
Generic name
Dbm Putty
Manufacturer
Apptec Laboratory ServicesModel number
NACatalog number
005110
Lot number
1261320022
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR
- Bacterial Infection
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION USING DBM PUTTY AT LEVELS L1-L5, FOR L3 BURST FRACTURE AS A RESULT OF A MOTOR VEHICLE ACCIDENT. NINE DAYS POST-OP, THE PATIENT DEVELOPED A SURGICAL SITE INFECTION. MICROBIAL CULTURES GREW (B)(6). THE PATIENT WAS TREATED WITH ANTIBIOTICS, IRRIGATION AND DEBRIDEMENT OF THE SURGICAL SITE AND REMOVAL OF THE ALLOGRAFT TISSUE. SINCE THEN THE PATIENT HAS BEEN DISCHARGED TO A CARE FACILITY.
Additional Manufacturer Narrative
(B)(4). 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. 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.