BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOFIL DBM PASTE

    MDR report key: 2190133 · Received February 27, 2007

    Report

    Report Number
    3002719998-2007-00002
    Event Type
    Injury
    Date Received
    February 27, 2007
    Report Date
    February 27, 2007
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: GRAFT (B)(6) NOT RETURNED TO RTI AND REMAINS IMPLANTED. INVESTIGATION. REVIEW OF INTERNAL RECORDS, DONOR RECORDS, TISSUE DONOR SEROLOGICAL TEST RESULTS, MEDICAL RELEASE, MFG HISTORY, QA/QC REVIEWS AND PROCESSING CULTURES. GRAFT (B)(6) PASSED ALL RELEASE CRITERIA PRIOR TO DISTRIBUTION. RESULTS: GRAFT (B)(6) WAS IRRADIATED WITHIN THE VALIDATED DOSAGE TO ELIMINATE POTENTIAL VIABLE MICROBES. REVIEW OF TUR DATABASE REVEALS 42 TISSUE UTILIZATION RECORDS RECEIVED FOR THIS DONOR WITH IMPLANT DATES RANGING FROM (B)(6) 2003 THROUGH (B)(6) 2004 WITH NO RELATED COMPLAINTS IDENTIFIED WHICH IMPLANTS FROM THIS DONOR. CONCLUSION: THE PROCESSING METHOD UTILIZED FOR THE GRAFT, IRRADIATION AND DEMINERALIZATION, ARE VALIDATED TO ELIMINATE THE POTENTIAL OF DISEASE TRANSMISSION. IT IS MORE REASONABLE THAT EXPOSURE TO (B)(6) IS DUE TO A SOURCE, EVENT, OR BEHAVIOR OTHER THAN ALLOGRAFT IMPLANT GIVEN THAT DONOR SEROLOGICAL TESTING RESULTS ARE NEGATIVE FOR (B)(6) AND THE PROCESSING METHODOLOGY UTILIZED FOR THE GRAFT.

    Description of Event or Problem · 1

    RECIPIENT CLAIMS THAT BLOOD TESTING RESULTS FOR VIRAL COMMUNICABLE DISEASES SHOWED EVIDENCE OF EXPOSURE TO (B)(6). GRAFT (B)(6) IS ASSOCIATED WITH BTS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOFIL DBM PASTE ALLOGRAFT BONE PASTE MQV REGENERATION TECHNOLOGIES, INC. 0245005 101032568

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening