BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION PIM

    MDR report key: 476502 · Received August 5, 2003

    Report

    Report Number
    1723170-2003-00003
    Event Type
    Malfunction
    Date Received
    August 5, 2003
    Date of Event
    July 22, 2003
    Report Date
    August 5, 2003
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HTY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    5" FIXTATION PIN BROKE OFF IN PELVIS AFTER HIP PROCEDURE. SURGEON ATTEMPTED TO REMOVE, HOWEVER, THE BREAK WAS BELOW THE BONE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXATION PIM ORTHOPEDIC FIXATION PUMP HTY MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES NA 200303030641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other