BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 16192663 · Received January 18, 2023

    Report

    Report Number
    3016571711-2022-00015
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 19, 2022
    Report Date
    December 19, 2022
    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

    XVISION WAS USED ON (B)(6) 2022 (L3-L5 FUSION). THE SURGEON HAD SOME ANATOMICAL ISSUES ON THE PATIENT'S RIGHT AT EACH LEVEL WHERE THE INITIAL TRAJECTORIES WERE MET WITH THE TAP AND DRIVER SKIVING. TRAJECTORIES WERE RESET AND SCREWS WERE PLACED. WHEN EXAMINING THE C-ARM CONFIRMATION IMAGES, THE ALIGNMENT OF THE L3 TRAJECTORIES WAS DIFFERENT, AND NO COMMENTS WERE PROVIDED FOR LL4 AND LL5 WHICH WERE FOUND LATER TOO MEDIAL AND CAUDAL. THE PATIENT DISPLAYED FOOT DROP DUE TO A PINCHED L4 NERVE AND REQUIRED REVISION SURGERY. REVISION SURGERY WAS HELD, AND ALL SCREWS WERE REMOVED. LEFT AND RIGHT L3, RIGHT L4, AND RIGHT L5 HAD SCREWS REPLACED ALONG THE PREVIOUS PATHWAYS. THE SCREWS IN LEFT L4 AND LEFT L5 WERE TOO MEDIAL AND CAUDAL, AND THEIR TRAJECTORIES WERE READJUSTED IN THE REVISION WITHOUT USING THE XVS SPINE SYSTEM. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CONTRIBUTING FACTOR TO DEVIATION IN THE TRAJECTORY OF LEFT L4 & LEFT L5 PEDICLE SCREWS IS A COMBINATION OF SOFT TISSUE PRESSURE AND TOOL SKIVING. THE MOST PROBABLE CAUSE FOR THE SCREWS' MISPLACEMENT IS DUE TO TOOL DEVIATION. HOWEVER, THE ROOT CAUSE, IN THIS CASE, CANNOT BE CONCLUDED CONCLUSIVELY. NO SW OR HW MALFUNCTIONS WERE FOUND DURING THE INVESTIGATION. AS THIS CASE ENDED WITH A REQUIRED REVISION CASE, IT WAS DECIDED THAT THIS EVENT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704 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