BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOFIL RT DBM PASTE

    MDR report key: 2190163 · Received February 27, 2007

    Report

    Report Number
    3002719998-2007-00001
    Event Type
    Injury
    Date Received
    February 27, 2007
    Report Date
    February 27, 2007
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. GRAFTS (B)(6) PASSED ALL RELEASE CRITERIA PRIOR TO DISTRIBUTION. RESULTS: DONOR SEROLOGICAL TESTING RESULTS WERE NEGATIVE FOR INFECTIONS DISEASE. GRAFT ID (B)(6) WAS IRRADIATED WITHIN THE VALIDATED DOSAGE TO ELIMINATE POTENTIAL VIABLE MICROBES. MOREOVER, THERE WAS NO INFO IN THE MEDICAL SOCIAL HISTORY ASSOCIATED WITH COMMUNICABLE DISEASE. REVIEW OF TUR DATABASE REVEALS 35 TISSUE UTILIZATION RECORDS RECEIVED FOR THIS DONOR WITH NO RELATED COMPLAINTS IDENTIFIED. CONCLUSION: THE PROCESSING METHOD UTILIZED FOR THE GRAFT, IRRADIATION AND DEMINERALIZATION, IS VALIDATED TO ELIMINATE THE POTENTIAL OF DISEASE TRANSMISSION. DONOR HISTORY NEGATIVE FOR RISK FACTORS AND SEROLOGICAL TESTING RESULTS ALL NEGATIVE. 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 ID (B)(6) ARE NOT ASSOCIATED WITH BT8 RECALL. RECIPIENT UNDERWENT CERVICAL DISKECTOMY AT (B)(6) HOSPITAL. DATE OF IMPLANT NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOFIL RT DBM PASTE ALLOGRAFT BONE PASTE MQV REGENERATION TECHNOLOGIES, INC. 004401 101029040

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening