BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON LEGACY SPINAL SYSTEM, BALL HANDLE PROBE

    MDR report key: 3951826 · Received July 17, 2014

    Report

    Report Number
    3951826
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TIP OF LENKE PROBE BROKE WHILE PREPARING ILIAC BOLT. APPROXIMATELY 30MM OF INSTRUMENT LEFT IN PATIENT'S RIGHT ILIAC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420044 CD HORIZON LEGACY SPINAL SYSTEM, BALL HANDLE PROBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA INC BALL HANDLED PROBE FA0C029

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR