BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 17787442 · Received September 21, 2023

    Report

    Report Number
    3016571711-2023-00011
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 21, 2023
    Manufacturer
    AUGMEDICS LTD.
    Product Code
    OLO
    UDI-DI
    07290113780231
    PMA / PMN Number
    K211188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER AN XLINK REGISTRATION, THE SURGEON COMPLETED A LANDMARK CHECK WITH A PROBE AND CONFIRMED ACCURACY. THE SURGEON THEN BROUGHT IN A BURR AND COMMENTED THAT IT WAS NOT ACCURATE. THE BURR WAS RECALIBRATED, BUT THE SURGEON STILL FELT THAT IT WAS INACCURATE. THE SURGEON PROCEEDED WITH THE LEFT L4-5 SCREWS AND TOOK FLUORO SHOTS. HE WAS UNHAPPY WITH SCREW PLACEMENT AND DECIDED TO RE-SPIN AND RE-REGISTER USING XLINK. HE CONFIRMED THE SECOND REGISTRATION AND ACCURACY OF THE BURR WITH LANDMARK CHECKS AND REPOSITIONED THE LEFT L4-5 SCREWS AND THEN COMPLETED THE RIGHT SIDE. THE REDIRECTED SCREWS, USING THE XVS SYSTEM AND THE SAME CALIBRATED TOOLS, WERE FOUND TO BE POSITIONED ACCURATELY, AS CONFIRMED WITH FLUORO. THE FACT THAT RE-SPINNING AND RE-REGISTRATION, USING THE SAME CALIBRATED TOOLS, RESULTED IN ACCURATE SCREW POSITIONING, SUGGESTS THAT THERE WAS A SLIGHT MOVEMENT OF EITHER THE PATIENT MARKER OR THE PATIENT AFTER THE FIRST REGISTRATION COMPLETION AND INSTRUMENTATION. NONE OF THE FINDINGS INDICATE A MALFUNCTION OF THE SYSTEM. THE INVESTIGATION CONCLUDED THAT THE EVENT WAS SOLELY THE RESULT OF A USER ERROR, HOWEVER, THIS ERROR LED TO THE REPOSITIONING OF THE SCREWS, WHICH CONSIDERED AS "SERIOUS INJURY". THEREFORE, IT WAS DECIDED TO REPORT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518736 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD. ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE NA 07290113780231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other