BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAC SP 09 NAVLOCK SEXTANT KIT

    MDR report key: 2012157 · Received February 1, 2011

    Report

    Report Number
    1723170-2011-00067
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K50438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVED WITH THIS CONCERN. A MEDTRONIC REP SOAKED THE INSTRUMENTS OVERNIGHT AND USED A K-WIRE AND HAMMER TO REMOVE ALL BONE FRAGMENTS FROM THE TAPS. AFTER REMOVAL OF ALL BONE FRAGMENTS, THE DEVICE WAS RE-AUTOCLAVED. THE INSTRUMENTS WERE THEN READY FOR USE. THE ISSUE WAS FOUND OUTSIDE OF SURGERY.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED RECEIVING A SEXTANT NAVLOCK KIT WITH BONE CAKED IN ALL OF THE TAPS. THIS DID NOT HAPPEN IN SURGERY AND THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAC SP 09 NAVLOCK SEXTANT KIT STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NAVLOCK INSTRUMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1