BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TRANSFIX IMPLANT, 5MM X 50MM

    MDR report key: 534106 · Received July 14, 2004

    Report

    Report Number
    1220246-2004-00051
    Event Type
    Other
    Date Received
    July 14, 2004
    Date of Event
    April 1, 2004
    Report Date
    June 23, 2004
    Manufacturer
    ARTHREX, INC.
    Product Code
    MNU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WENT IN FOR IT BAND IRRITATION DUE TO A PORTION OF THE IMPLANT MIGRATING OUT OF THE BONE. ABOUT A 15MM PORTION OF THE IMPLANT SEEMED TO HAVE MIGRATED OUT OF THE BONE. DURING SECOND SURGERY, THE IMPLANT SHOWED NO RESISTANCE WHEN SURGEON REMOVED. THE PT AT THIS TIME WAS FULLY HEALED AND IS DOING WELL.

    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 28588

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R