BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM

    MDR report key: 3983070 · Received August 6, 2014

    Report

    Report Number
    0001811755-2014-02805
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    January 10, 2025
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED THROUGH SERVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE NAVLOCK UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM FELL APART WHILE UNSCREWING A PIECE WITH A SCREWDRIVER. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE NAVLOCK UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM FELL APART WHILE UNSCREWING A PIECE WITH A SCREWDRIVER. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460992 NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO A/01/2014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown