Description of Event or Problem · 1
RTI BIOLOGICS, INC. (RTI) HAS INITIATED AN INVESTIGATION BASED ON A COMPLAINT OF POST-OPERATIVE INFECTION REPORTED ON (B)(6) 2012. ON (B)(6) 2012, THE PT UNDERWENT A BILATERAL BREAST RECONSTRUCTION WITH ALLOMAX DERMIS GRAFTS. GRAFT ID (B)(4) WAS IMPLANTED ON THE LEFT SIDE. ON (B)(6) 2012, THE LEFT EXPANDER WAS REMOVED. FINAL CULTURES (LEFT SIDE) YIELDED PSEUDOMONAS AERUGINOSA. THE SURGEON REPORTED HE HAS HAD AN INCREASE IN GRAM NEGATIVE INFECTIONS IN SEVERAL PTS POST BREAST RECONSTRUCTION SURGERY. THE SURGEON IS REQUESTING A REVIEW OF RECORDS RELATED TO THE TISSUE. NO COMPLICATIONS WERE REPORTED WITH THE GRAFT IMPLANTED ON THE RIGHT SIDE. BOTH DONOR AND MANUFACTURING RECORDS ARE RE-REVIEWED AS PART OF RTI'S INVESTIGATION. NO DEVIATIONS WERE NOTED FOR THE DONOR AND ALL RTI DONOR ELIGIBILITY REQUIREMENTS WERE MET. PRE-STERILIZATION CULTURES FROM DONOR (B)(4) YIELDED BACILLUS SPP. ON 1 TENDON TISSUE. BACILLUS IS ACCEPTABLE TO BE PRESENT ON TISSUE PRIOR TO PROCESSING BASED ON STERILIZATION VALIDATION. THE ALLOGRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST WHICH INCLUDES TERMINAL STERILIZATION WITH GAMMA IRRADIATION. NO DEVIATIONS WERE NOTED DURING POST TUTOPLAST PROCESSING AND ENVIRONMENTAL MONITORING RESULTS WERE ACCEPTABLE DURING AND AROUND THE TIME OF POST TUTOPLAST PROCESSING. REVIEW OF PRE TUTOPLAST PROCESSING AND ENVIRONMENTAL MONITORING ARE PENDING. RTI AND ITS SUBSIDIARY RECOVERED AND RECEIVED ALL MUSCULOSKELETAL/DERMAL TISSUE FROM DONOR (B)(4). RTI HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF (B)(4) ALLOGRAFTS FROM DONOR (B)(4) AND RECEIVED (B)(4) RECORDS OF IMPLANTATION WITH (B)(4) RECORDS SPECIFIC TO DERMIS ALLOGRAFTS. NO RELATED COMPLAINTS HAVE BEEN REPORTED ASSOCIATED WITH ALLOGRAFTS DISTRIBUTED FROM THE DONOR. THE GRAFTS WERE MANUFACTURED ACCORDING TO SPECIFICATION. TO DATE, OUR INVESTIGATION IS WITHOUT INDICATION THAT THE GRAFT CONTRIBUTED TO COMMUNICABLE DISEASE TRANSMISSION. ON (B)(6) 2012, THE LEFT BREAST WAS ASPIRATED AND 120ML OF SLIGHTLY TURBID FLUID WAS OBTAINED. FINAL CULTURES YIELDED PSEUDOMONAS AERUGINOSA. ON (B)(6) 2012, LEFT EXPANDER AND ALLOGRAFT WERE REMOVED. ON (B)(6) 2012, RIGHT BREAST TISSUE EXPANDER AND CAPSULE WERE REMOVED. THE SURGEON REPORTED HE HAS HAD AN INCREASE IN GRAM NEGATIVE INFECTIONS IN SEVERAL PTS POST BREAST RECONSTRUCTION SURGERY. THE SURGEON IS REQUESTING A REVIEW OF RECORDS RELATED TO THE TISSUE. NO COMPLICATIONS WERE REPORTED WITH THE GRAFT IMPLANTED ON THE RIGHT SIDE. BOTH DONOR AND MANUFACTURING RECORDS WERE REREVIEWED AS PART OF RTI'S INVESTIGATION. NO DEVIATIONS WERE NOTED FOR THE DONOR AND ALL RTI ELIGIBILITY REQUIREMENTS WERE MET. PRE-STERILIZATION CULTURES FROM DONOR (B)(4) YIELDED BACILLUS SPP. ON 1 TENDON TISSUE. BACILLUS IS ACCEPTABLE TO BE PRESENT ON TISSUE PRIOR TO PROCESSING BASED ON STERILIZATION VALIDATION; BIOCLEANSE. NO DEVIATIONS WERE NOTED PRE-TUTOPLAST, DURING TUTOPLAST OR POST TUTOPLAST PROCESSING FOR THE DONOR. ENVIRONMENTAL MONITORING WAS ACCEPTABLE DURING AND AROUND THE TIME OF PROCESSING. RTI AND ITS SUBSIDIARY RECOVERED AND RECEIVED ALL MUSCULOSKELETAL/DERMAL TISSUE FROM DONOR (B)(4). RTI HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF (B)(4) ALLOGRAFTS FROM DONOR (B)(4) AND RECEIVED (B)(4) RECORDS OF IMPLANTATION WITH (B)(4) RECORDS SPECIFIC TO DERMIS ALLOGRAFTS. NO RELATED COMPLAINTS HAVE BEEN REPORTED ASSOCIATED WITH ALLOGRAFTS DISTRIBUTED FROM THE DONOR. THE GRAFT WAS MFG ACCORDING TO SPECIFICATION. TO DATE, OUR INVESTIGATION IS WITHOUT INDICATION THAT THE GRAFT CONTRIBUTED TO COMMUNICABLE DISEASE TRANSMISSION. (B)(4).