BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10561746 · Received September 21, 2020

    Report

    Report Number
    1723170-2020-02490
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 21, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MODEL NUMBER AND LOT NUMBER UNAVAILABLE. UDI NOT AVAILABLE. 510K UNKNOWN AS DEVICE MODEL NUMBER IS UNKNOWN. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PEDICLE SCREWS (PS) OF LEFT L5 WERE INSTALLED BY USING NAVIGATION, THE PROBE, TAP, AND DRIVER. WHEN THE PS WAS INSERTED, THE BONE WAS VERY HARD AND THE SCREW WORKED, BUT IT WAS SUSPECTED TO BE TOO EFFECTIVE. THE SCREW AT THE TIP OF THE DRIVER WAS CUT OFF JUST BEFORE THE INSTALLATION WAS COMPLETED. SINCE THE THREADED TIP COULD NOT BE TAKEN OUT, A SHORT ROD WAS INSTALLED, AND A FINAL INSTALLATION WAS PERFORMED. REMOVAL WAS PERFORMED BY USING A ROD GRIPPER, AND A NEW SCREW WITH A LENGTH OF 5 MM WAS INSTALLED. THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WERE NO ANOMALIES SUCH AS BROKEN BONES. THERE WAS A DELAY OF LESS THAN AN HOUR. THERE WAS NO IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023900 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_COMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1