BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV LOCK AWL TIP

    MDR report key: 2058739 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00429
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER RMA, A REPLACEMENT AWL TIP WAS SENT TO SITE. UPON EVALUATION OF RETURNED AWL, THE TIP OF THE TOOL IS BENT AND SLIGHTLY TWISTED. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED, THE SURGEON WAS USING A NAV LOCK PROBE TO CREATE A HOLE IN THE PEDICLE FOR THE SCREW. AS THE SURGEON PULLED THE PROBE OUT, HE SAW THAT THE SHAFT WAS BENT. MEDTRONIC REPRESENTATIVE REPORTS THAT THE SURGEON WAS NOT USING EXCESSIVE FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV LOCK AWL TIP STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 100513

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK