ORTHOBLAST-II PUTTY

Additional Manufacturer Narrative

ADDITIONAL LOT # 102964. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. INTEGRA'S INVESTIGATION WAS UNABLE TO CONFIRM THAT THE COMPLAINT WAS ATTRIBUTED TO OUR PRODUCTS. THE PRODUCT WAS STERILIZED WITHIN SPECIFICATIONS. THE STERILIZATION DOSE HAS BEEN VALIDATED TO PROVIDE A STERILITY ASSURANCE LEVEL SUCH THAT THE PROBABILITY OF HAVING CONTAMINATION IS ONE IN ONE-MILLION. THE PACKAGING HAS BEEN VALIDATED. PRODUCT IS PLACED INTO A TORQUED VIAL AND DOUBLE PACKAGED WITH A TYVEK LID, RESULTING IN A WELL-SEALED BARRIER TO OUTSIDE CONTAMINANTS.

Description of Event or Problem

INTEGRA RECEIVED A REQUEST FROM THE USER FACILITY FOR INFORMATION REGARDING THE PRODUCT'S HISTORY RECORD. THE HOSPITAL HAD TWO PATIENTS WHO HAD SURGERY ON THE SAME DAY WHO DEVELOPED WOUND INFECTIONS. IT WAS REPORTED THAT ON (B)(6), 2011 THE PATIENT HAD A LAMINECTOMY/FUSION SPINAL SURGERY PROCEDURE. THE PATIENT WAS READMITTED FOUR DAYS LATER WITH AN INFECTION IN THE LUMBAR SURGICAL INCISION. WOUND CULTURE CONFIRMED THAT MICROORGANISMS ENTEROCOCCUS FAECALIS WERE PRESENT. THE PATIENT RETURNED TO THE OPERATING ROOM FOR INCISION AND DRAINAGE OF THE WOUND INFECTION, WITH REMOVAL OF ALL THE BONE GRAFT THAT WAS PLACED ON (B)(6), 2011. A WOUND DRAIN WAS PLACED. THE PATIENT WAS SEEN BY AN INFECTIOUS DISEASE PHYSICIAN. A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WAS PLACED ON (B)(6), 2011 BEFORE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, WITH FOLLOW UP FROM THE VISITING NURSE AND INFECTIOUS DISEASE PHYSICIAN.