BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL TIBIAL TRAY IMPACTOR TIP

    MDR report key: 3173183 · Received May 31, 2013

    Report

    Report Number
    3004153240-2013-00090
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CONFORMIS
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. DEVICE LOT WAS NOT PROVIDED. DEVICE WAS NOT RETURNED. INVESTIGATION CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE REUSABLE TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TIP CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241710 ITOTAL TIBIAL TRAY IMPACTOR TIP REUSABLE IMPACTOR COMPONENT LXH CONFORMIS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR