BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4223072 · Received November 4, 2014

    Report

    Report Number
    0001811755-2014-03937
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED THROUGH SERVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAVLOCK, UNIVERSAL TRACKER ADAPTER HAD A MISSING POST AND A BROKEN AND MISSING STOPPER DURING TESTING AT THE USER FACILITY. 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 THE NAVLOCK, UNIVERSAL TRACKER ADAPTER HAD A MISSING POST AND A BROKEN AND MISSING STOPPER DURING TESTING AT THE USER FACILITY. 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 THE NAVLOCK, UNIVERSAL TRACKER ADAPTER HAD A MISSING POST AND A BROKEN AND MISSING STOPPER DURING TESTING AT THE USER FACILITY. 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
    705696 NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO U8

    Patients

    Seq Age Sex Outcome Treatment
    1