BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL GUIDE

    MDR report key: 2043281 · Received February 25, 2011

    Report

    Report Number
    1723170-2011-00162
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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

    DEVICE MFR DATE WAS UNK AS NO LOT NUMBER WAS PROVIDED. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A RMA WAS ISSUED FOR THE REPLACEMENT OF THE PART.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE UNIVERSAL DRILL GUIDE (UDG) STEM IS PULLING AWAY FROM THE HANDLE. THIS PART WAS USED WITH THE STEALTHSTATION TREON. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL GUIDE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1