BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TRANSFIX, 5MM X 40MM, LONG

    MDR report key: 619907 · Received June 30, 2005

    Report

    Report Number
    1220246-2005-00105
    Event Type
    Injury
    Date Received
    June 30, 2005
    Date of Event
    May 1, 2005
    Report Date
    June 27, 2005
    Manufacturer
    ARTHREX, INC.
    Product Code
    MNU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT ACQUIRED A POST OP INFECTION SOME 30 DAYS FROM INITIAL SURGERY. THREE TOTAL ARTHREX IMPLANTS WERE INVOLVED ALONG WITH A MITEK IMPLANT. GRAFT TYPE USED WAS AN AUTOGRAFT. CULTURE WAS TAKEN AND TESTED POSITIVE FOR STAPHYLOCOCCUS. ALL HARDWARE WAS REMOVED FROM THE PT AND ANTIBIOTICS WERE ADMINISTERED. PT CURRENTLY IN GOOD CONDITION. REFERENCE CA37126A AND CA37126C FOR THE ADDITIONAL IMPLANTS IN PT. ONE OTHER PT, PRESENTING ALSO A POST OP INFECTION WAS REPORTED UNDER CA37128. PT WAS OPERATED ON THE SAME DAY, BY THE SAME SURGEON AT THE SAME FACILITY. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TRANSFIX, 5MM X 40MM, LONG GRAFT FIXATION DEVICE MNU ARTHREX, INC. AR-1351B 57607

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention