BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 PREMIUM

    MDR report key: 10236481 · Received July 6, 2020

    Report

    Report Number
    1723170-2020-01840
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 6, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS SERVICED IN THE FIELD. THE SYSTEM PASSED ALL TESTS AND WAS PERFORMING AS INTENDED. NO FAILURES WERE FOUND. 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 DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN NAVIGATING THE INSTRUMENTS, THE SITE WAS ON THE RIGHT PEDICLE, BUT THE NAVIGATION SYSTEM WAS SHOWING THAT THE SITE WAS ON THE LEFT PEDICLE. THE INFORMATION WAS FLIPPED. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE IMAGE WAS USED TO ASSESS THE TRAJECTORY OF THE SCREW. IT WAS REPORTED THAT THE LIKELY CAUSE WAS THAT THE PERSON THAT WAS RUNNING THE SYSTEM HAD HIT THE "FLIP" BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695987 S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1