BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL TIBIAL TRAY IMPACTOR TIP

    MDR report key: 3063368 · Received March 28, 2013

    Report

    Report Number
    3004153240-2013-00057
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CONFORMIS
    Product Code
    LXH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. REVIEW OF INSPECTION RECORDS INDICATE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    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
    128928 ITOTAL TIBIAL TRAY IMPACTOR TIP REUSABLE IMPACTOR TIP LXH CONFORMIS K120801

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR