ACCELL EVO3 10CC

Description of Event or Problem

THIS IS THE FIRST REPORT OF TWO CONCERNING THE SAME PT AND SAME PRODUCT. THIS REPORT CONCERNS ACCELL EVO3 22CC LOT# 131350. IT WAS REPORTED THE PT ENROLLED IN A POST MARKET CLINICAL STUDY TITLED (B)(6) EXPERIENCED A POST-SURGICAL INFECTION REQUIRING HOSPITALIZATION, SURGERY AND MEDICATION. IT WAS REPORTED THE PT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) L3-L5 ON (B)(6) 2013 WITH ACCELL EVO3 20CC AND 30CC OF AUTOGRAFT. STRYKER RADIUS DEVICE WAS USED FOR FIXATION. THE PT REPORTEDLY DID WELL UNTIL APPROX TWO WEEKS POST-OPERATIVELY AND PRESENTED WITH FEVERS, MALAISE, AND SIGNIFICANT ERYTHEMA AND DRAINAGE OF PURULENCE FROM THE WOUND. HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013. BLOOD CULTURES WERE OBTAINED THAT SHOWED GRAM STAIN POSITIVE FOR GRAM-POSITIVE COCCI. HE WAS DIAGNOSED WITH AN INFECTED POSTERIOR LUMBAR SPINAL WOUND AND WAS TREATED WITH INTRAVENOUS VANCOMYCIN AND AN INFECTIOUS DISEASE SPECIALIST WAS CONSULTED. ON (B)(6) 2013 THE PT UNDERWENT COMPLEX IRRIGATION AND DEBRIDEMENT OF THE POSTERIOR LUMBAR WOUND WITH A DRAIN. THE IMPLANTED HARDWARE AND EVO3 WERE NOT EXPLANTED DURING THE IRRIGATION AND DEBRIDEMENT SURGERY. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. HE IS BEING TREATED WITH A BRACE, BONE STIMULATOR, A HOME CARE NURSE AND MEDICATION. ON (B)(6)2013, THE PTS SUTURES WERE REMOVED AND SAID HE FELT "REALLY GOOD".

Additional Manufacturer Narrative

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.