BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTILE AWL

    MDR report key: 3160144 · Received June 10, 2013

    Report

    Report Number
    1723170-2013-00423
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE IS UNAVAILABLE AT THIS TIME. RMA ISSUED. REPLACEMENT TACTILE AWL SHIPPED TO SITE (B)(6) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT, AS REPORTED, THE TIP OF THE INSTRUMENT IS VISIBLY BENT. PHYSICAL DAMAGE/DEFORMATION DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINE PROCEDURE, A TACTILE AWL WAS BENT WHILE PERFORMING A L4-S1 FUSION. THE SURGEON NOTED THE BONE WAS VERY HARD AND WHEN USING THE AWL, THE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260690 TACTILE AWL NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 111221

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR