BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 22963032 · Received September 4, 2025

    Report

    Report Number
    3016571711-2025-00019
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 4, 2025
    Manufacturer
    AUGMEDICS LTD.
    Product Code
    OLO
    PMA / PMN Number
    K220905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN OPEN T1-T8 PROCEDURE, THE NAVIGATION CLAMP BECAME TEMPORARILY DISLODGED FROM THE PATIENT'S SPINOUS PROCESS AFTER THE INITIAL SCAN AND LANDMARK CHECK, LEADING TO NAVIGATION INACCURACY AND REQUIRING THE REDIRECTION OF TWO SCREWS. THE CLAMP WAS THEN REPOSITIONED ONE LEVEL LOWER, REMAINED STABLE, AND NAVIGATION ACCURACY WAS RESTORED, ALLOWING THE PROCEDURE TO CONTINUE SUCCESSFULLY WITHOUT PATIENT HARM. INVESTIGATION DETERMINED THAT THE EVENT RESULTED FROM CLAMP MOVEMENT, LIKELY INFLUENCED BY PATIENT ANATOMY AND BONE QUALITY, RATHER THAN A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450262 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD. ALL-IN-ONE COMPUTER + PRE-INSTALLED SOFTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other