BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTP FUSION PLATE

    MDR report key: 1149418 · Received August 19, 2008

    Report

    Report Number
    2030833-2008-00004
    Event Type
    Other
    Date Received
    August 19, 2008
    Report Date
    August 18, 2008
    Manufacturer
    TORNIER INC.
    Product Code
    HRS
    PMA / PMN Number
    K053408
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MTP-PS2L PRIMARY PLATE WAS IMPLANTED. PLATE BROKE INSIDE THE PATIENT. SECOND SURGERY WAS CONDUCTED TO REMOVE THE PLATE IN 2008. CURRENTLY, TORNIER, INC IS TRYING TO OBTAIN MORE INFORMATION ON THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTP FUSION PLATE PRIMARY MTP PLATE HRS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention