BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL/PROBE/TAP DRIVER

    MDR report key: 2181444 · Received July 5, 2011

    Report

    Report Number
    1723170-2011-01188
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    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

    PT IDENTIFIER IS NOT AVAILABLE FOR THE SITE. LOT NUMBER FOR THIS DEVICE NOT AVAILABLE AT THE TIME OF THIS REPORT. DEVICE MFR DATE CANNOT BE DETERMINED UNTIL THE LOT NUMBER IS MADE AVAILABLE. PART NOT RETURNED. MEDTRONIC REP AT THE SITE WAS UNABLE TO REPLICATE THE ISSUE; ALSO CONFIRMED THAT THE INSTRUMENTATION IS IN WORKING ORDER WITH NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THE APT AWL (AWL/PROBE/TAP) WAS INSERTED INTO THE VERTEBRAL BODY, AND WHEN THE GEOMETRIC ARRAY/HANDLE WAS ROTATED, THE CROSS-HAIRS MOVED EVEN THOUGH THE AWL TIP WAS NOT. NO IMPACT ON PT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL/PROBE/TAP DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR