BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM

    MDR report key: 3895079 · Received June 25, 2014

    Report

    Report Number
    0001811755-2014-02272
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 30, 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
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED THROUGH THE SERVICE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER WAS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM OF THE NAVLOCK UNIVERSAL TRACKER ADAPTOR FOR INSTRUMENTS BROKE OFF DURING A FRONTAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY USING NAVIGATION AND WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM OF THE NAVLOCK UNIVERSAL TRACKER ADAPTOR FOR INSTRUMENTS BROKE OFF DURING A FRONTAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY USING NAVIGATION AND WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM OF THE NAVLOCK UNIVERSAL TRACKER ADAPTOR FOR INSTRUMENTS BROKE OFF DURING A FRONTAL ENDOSCOPIC SINUS SURGERY PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY USING NAVIGATION AND WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371785 NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO A/01/2014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown