BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TRANSFIX IMPLANT, 5MM X 50MM

    MDR report key: 534099 · Received July 14, 2004

    Report

    Report Number
    1220246-2004-00050
    Event Type
    Other
    Date Received
    July 14, 2004
    Date of Event
    November 13, 2003
    Manufacturer
    ARTHREX, INC.
    Product Code
    MNU
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BIO-TRANSFIX IMPLANT BROKE IN HALF POST-OP. DEVICE WAS IMPLANTED DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE PERFORMED IN 2002. LATERAL PAIN STARTED IN 2003. THE REVISION SURGERY OCCURRED 5 MONTHS LATER. AT THE TIME OF REMOVAL, THE PT WAS NOTED TO BE FULLY HEALED. FOLLOW UP INFO OBTAINED IN 2004 REVEALED PT IS IN SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TRANSFIX IMPLANT, 5MM X 50MM ACL RECONSTRUCTION - GRAFT FIXATION DEVICE MNU ARTHREX, INC. AR-1351LB 33208

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other