PROGENIX DBM PUTTY 5CC
Received Sep 17, 2009 · Event occurred Aug 18, 2009
Report 1030489-2009-00862 · MDR key 1476986
Device
Generic name
Dbm Putty
Manufacturer
Apptec Laboratory ServicesModel number
NACatalog number
005005
Lot number
1180800030
Product problems
- Insufficient Device Problem Information
Patient
62 YR
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PT UNDERWENT A FUSION PROCEDURE USING DEMINERALIZED BONE MATRIX PUTTY. ELEVEN DAYS POST-OP, THE PT PRESENTED WITH AN INFECTION. A SECOND SURGERY TO WASHOUT THE WOUND WAS PERFORMED, AND A DRAIN WAS PLACED. DURING THE WASHOUT PROCEDURE, THE DEMINERALIZED BONE MATRIX WAS REMOVED.
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORDS AND DONOR HISTORY RECORDS FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION, OR PROCESS DEVIATIONS WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.