ALLOCRAFT DBM

Description of Event or Problem

ON (B)(6) 2011 THE PATIENT HAD BONE GRAFT AND 2 ALLOGRAFT INJECTIONS. THE PATIENT DEVELOPED POST-OPERATIVE INFECTION THAT WAS TREATED WITH ANTIBIOTICS AND DEBRIDEMENT OF WOUND. IT WAS REPORTED THAT CULTURE WAS TAKEN BUT LIFECELL HAS NOT BEEN ABLE TO OBTAIN THE CULTURE RESULTS.

Description of Event or Problem

THIS IS A FOLLOW-UP REPORT TO MDR 1000306051-2011-0016.

Additional Manufacturer Narrative

REVIEW OF THE DEVICE HISTORY RECORDS FOR LOTS B11E09A (MANUFACTURE DATE: 03/22/2011, EXP 12/31/2012) AND B11A31A (MANUFACTURE DATE:01/19/2011, EXP. 11/30/2012). QUERY OF LIFECELL COMPLAINT SYSTEM FOR ANY ISSUES OR OTHER COMPLAINTS REPORTED AGAINST DEVICES DISTRIBUTED FROM THESE LOTS. REVIEW OF THE DEVICE HISTORY RECORDS RESULTED IN NO REMARKABLE FINDINGS. AS OF (B)(4) 2011, ALL 81 DEVICES FROM THE AFFECTED LOTS WERE DISTRIBUTED WITH NO ISSUES OR OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THESE LOTS. BASED ON INTERNAL INVESTIGATION, THE DEVICE MET RELEASE CRITERIA FOR FINISHED PRODUCT AT THE TIME OF RELEASE. DUE TO LIMITED INFORMATION RECEIVED, THIS EVENT IS BEING REPORTED. LIFECELL WILL FILE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE WAS NOT RETURNED TO LIFECELL.

Additional Manufacturer Narrative

ON (B)(6) 2011, LIFECELL RECEIVED CULTURE RESULTS FROM (B)(6) THAT WERE FORWARDED TO (B)(6)FROM THE COMPLAINANT. IT WAS REPORTED THAT THE PATIENT HAD INTRA-OPERATIVE CULTURES DONE, BOTH DEEP AND SUPERFICIAL. DEEP WAS (B)(6) AND NO GROWTH ON GRAM STAIN. SUPERFICIAL WAS (B)(6). THE PATIENT WAS TREATED WITH I.V. VANCOMYCIN AND HAD INCISION AND DRAINAGE OF WOUND X2. THE SURGEON HAS STATED IN WRITING THAT HE DOES NOT BELIEVE THE INFECTION WAS CONNECTED TO THE PRODUCT IMPLANTED. (B)(6), THE SUPPLIER OF THE DBM COMPONENT, REPORTED THAT A TOTAL OF 185 CULTURES WERE PERFORMED THROUGHOUT ASEPTIC RECOVERY AND PROCESSING OF THE TWO DONORS INVOLVED IN THIS COMPLAINT. 47 OUT OF 51 PROCUREMENT CULTURES AND ALL 134 FINAL PROCESSING CULTURES (INCLUDING 10% DESTRUCTIVE TESTING CULTURES) WERE NEGATIVE. NON-PATHOGENS (CNS AND PROPIONIBACTERIUM ACNES) WERE ISOLATED FROM 4 PROCUREMENT CULTURES. OF THE 197 RELEASED ALLOGRAFTS, THERE HAVE BEEN NO OTHER REPORTS OF ADVERSE REACTIONS TO DATE. PER THE IMPLANTING PHYSICIAN, THE PATIENT IS DOING WELL. THE PHYSICIAN INDICATED THAT THE PATIENT HAS OTHER FACTORS CONTRIBUTING TO HIS POOR HEALTH, AND THAT FACT COMBINED WITH AN EXPECTED SMALL PERCENTAGE OF INFECTIONS IN SPINAL SURGERIES LEAVES HIM WITH NO COMPLAINTS ABOUT THE TISSUE.