PROGENIX PLUS

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HISTORY OF BACK RADICULAR SYMPTOMS AND FAILED CONSERVATIVE MEASURES OF RECURRENT L2-S1 SPONDYLOLISTHESIS AND STENOSIS. THE PATIENT UNDERWENT A REDO OF L1-S1 LAMINECTOMIES WITH L2 THRU S1 BILATERAL OSTEOTOMIES AND DISKECTOMIES WITH INTERBODY FUSIONS WITH PEEK CAGES WITH AUTOGRAFT, ALLOGRAFT AND BMP AS WELL AS L2-S1 PEDICLE SCREW FUSION WITH AUTOGRAFT, ALLOGRAFT BONE AND BMP WITH REDUCTION IN SPONDYLOLISTHESIS WITH INTRAOPERATIVE MICROSCOPY, FLUOROSCOPY, AND IMPLANTATION OF 2 INTRAMUSCULAR PAIN PUMPS THRU 2 SEPARATE STAB INCISIONS. PER THE OPERATIVE NOTES, THIS WAS AN EXTRA EFFORT CASE SECONDARY TO MORBIDLY OBESE PATIENT (B)(6) WITH SIGNIFICANT INCREASE IN TIME AND EXPOSURE AND DEFINITIVE PROCEDURE. AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED AN INFECTION. REVISION SURGERY IS TBD.

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# 1409090048, LOT# 1409090046, LOT# 1409090037, AND LOT# 1409090042. 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.