BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS CANCELLOUS XENOGRAFT PARTICLES

    MDR report key: 5730218 · Received June 16, 2016

    Report

    Report Number
    3002924436-2016-00004
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 16, 2016
    Manufacturer
    RTI SURGICAL, INC
    Product Code
    LPK
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SUBMITTED 06/16/16 IN ERROR. COPIOS CANCELLOUS XENOGRAFT PARTICLES ARE DISTRIBUTED REST OF WORLD AND (B)(4) DOES NOT DISTRIBUTE THE SAME OR SIMILAR PRODUCTS IN THE UNITED STATES, THEREFORE, NO REPORTING IS REQUIRED

    Additional Manufacturer Narrative · 1

    METHOD: THE GRAFT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A RE-REVIEW WAS PERFORMED OF THE MANUFACTURING RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUALITY CONTROL/ASSURANCE REVIEWS AND RELEASE, AND THE COMPLAINTS DATABASE FOR RELATED COMPLAINTS ASSOCIATED WIT THE LOT. RESULTS: THERE WAS ONE DEVIATION NOTED FOR LOT# NZ-162-24-05-12 RELATED TO INSTRUMENTATION DURING RECEIPT OF BOVINE TISSUE. AFTER, INVESTIGATION IT WAS DETERMINED THERE WAS NO RISK ASSOCIATED TO TISSUE AND THE TISSUE WAS APPROVED FOR FURTHER PROCESSING. THE GRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST ® WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING FOR THIS LOT WERE ACCEPTABLE. TO DATE (B)(4) HAS DISTRIBUTED (B)(4) XENOGRAFTS FROM THIS LOT WITHOUT RELATED COMPLAINTS FOR THE LOT. CONCLUSION: GIVEN THE FACT THAT: THE DEVICE WAS NOT RETURNED FOR EVALUATION; RECORDS REVIEW DEMONSTRATED NO DEVIATIONS THAT HAD A NEGATIVE IMPACT DURING MANUFACTURING OF GRAFT ID (B)(4); THE GRAFT MET SPECIFICATION REQUIREMENTS AND RELEASE CRITERIA AT THE TIME OF DISTRIBUTION; AND NO RELATED COMPLAINTS WERE NOTED ASSOCIATED WITH DISTRIBUTED GRAFTS FROM THIS LOT, IT IS UNLIKELY THAT THIS EVENT IS RELATED TO THE XENOGRAFT.

    Description of Event or Problem · 1

    (B)(4) AND TUTOGEN MEDICAL (B)(4), A WHOLLY OWNED SUBSIDIARY OF (B)(4), RECEIVED A REPORT FROM THE (B)(6) AUTHORITY DIRECTLY FROM THE CUSTOMER THAT AN INFECTION WAS NOTED. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384440 COPIOS CANCELLOUS XENOGRAFT PARTICLES XENOGRAFT CANCELLOUS PARTICLES LPK RTI SURGICAL, INC NZ-162-24-05-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other