PROGENIX DBM PUTTY

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RECURRENT L2-L5 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT REDO L1-L5 LA MINECTOMIES WITH L2 THRU L5 BILATERAL OSTEOTOMIES AND DISKECTOMIES WITH INTERBODY FUSION AND L2-L5 PEDICLE SCREW FUSION WITH REDUCTION OF SPONDYLOLISTHESIS. AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH A LUMBAR FLUID COLLECTION. AT 51 DAYS POST-OP, THE PATIENT UNDERWENT A SURGERY TO EXPLORE THE LUMBAR FUSION. NO PUS WAS SEEN, AND THE WOUND WAS COPIOUSLY IRRIGATED.

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 # 1297470042, LOT # 1394550039 AND LOT # 1394550041. EXPIRATION DATE FOR LOT 1297470042 IS 11/23/2011; EXPIRATION DATE FOR LOT 1394550039 IS 6/14/2012; EXPIRATION DATE FOR LOT 1394550041 IS 6/14/2012. (B)(4). MANUFACTURE DATE FOR LOT 1297470042 IS 11/20/2009; MANUFACTURE DATE FOR LOT 1394550039 IS 6/11/2010; MANUFACTURE DATE FOR LOT 1394550041 IS 6/11/2010. 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 NONCONFORMANCE TO SPECIFICATION.