BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOFIL DEM PASTE

    MDR report key: 929584 · Received October 19, 2007

    Report

    Report Number
    3002719998-2007-00009
    Event Type
    Injury
    Date Received
    October 19, 2007
    Date of Event
    January 16, 2006
    Report Date
    October 19, 2007
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GRAFT ID 2842693 WAS NOT RETURNED FOR RTI AND REMAINS IMPLANTED. INVESTIGATION: REVIEW OF INTERNAL RECORDS, MEDICAL RELEASE, MANUFACTURING HISTORY, AND QA/QC REVIEWS PERFORMED. A GRAFT FROM THE SAME MANUFACTURING EPISODE AND DONOR ID WAS SUBMITTED TO AN INDEPENDENT LABORATORY FOR THE DETECTION OF HEPATITIS C VIRAL NUCLEIC ACID (DNA/RNA) BY QUANTITATIVE POLYMERASE CHAIN REACTION TESTING. NO RECIPIENT SCREENING OR CONFIRMATORY TESTING RESULTS HAVE BEEN PROVIDED TO RTI TO DATE. RESULTS: THE GRAFT UNDERWENT ALL NORMAL PROCESSING METHODS INCLUDING DEMINERALIZATION AND IRRADIATION AT A VALIDATED DOSAGE TO ELIMINATE POTENTIAL VIABLE MICROBES. GRAFT ID 2842693 PASSED ALL RELEASE CRITERIA PRIOR TO DISTRIBUTION. FURTHERMORE, INDEPENDENT TESTING RESULTS OF A GRAFT FROM THE SAME MANUFACTURING EPISODE AND DONOR WAS NEGATIVE FOR THE PRESENCE OF HCV RNA. CONCLUSION: THE PROCESSING METHOD UTILIZED FOR THE GRAFT; IRRADIATION AND DEMINERALIZATION, ARE VALIDATED TO ELIMINATE THE POTENTIAL OF DISEASE TRANSMISSION. FURTHERMORE, TESTING CONCLUDED AN ASSOCIATED GRAFT WAS NEGATIVE FOR HCV. THE RIGOROUS TESTING THAT HAS BEEN PERFORMED ON THE DONOR TISSUES, COUPLED WITH THE FACT THAT RTI'S PROCESSES ARE VALIDATED TO ELIMINATE THE POTENTIAL FOR VIRAL TRANSMISSION THROUGH AN ALLOGRAFT IMPLANT INDICATES THAT THE RECIPIENT LIKELY CONTRACTED THE VIRUS FROM A SOURCE OTHER THAN THE ALLOGRAFT IMPLANT.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED RECIPIENT TESTED POSITIVE FOR HEPATITIS C ON INITIAL SCREENING TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOFIL DEM PASTE BONE PASTE MQV REGENERATION TECHNOLOGIES, INC. 002410 101041919

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention