BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL TIBIAL IMPACTOR TIP

    MDR report key: 2831408 · Received October 11, 2012

    Report

    Report Number
    3004153240-2012-00086
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 17, 2012
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HSH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TRAY CONNECTS TO THE IMPACTOR HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    TIBIAL TRAY IMPACTOR TIP BROKE AT THE POINT WHERE THE TRAY CONNECTS TO THE IMPACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITOTAL TIBIAL IMPACTOR TIP REUSABLE IMPACTOR TIP HSH CONFORMIS, INC. G1219

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR