BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 25092530 · Received May 6, 2026

    Report

    Report Number
    3016571711-2026-00002
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 5, 2026
    Manufacturer
    AUGMEDICS LTD.
    Product Code
    SBF
    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

    AN OPEN SPINAL PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, NAVIGATION INACCURACIES WERE IDENTIFIED AT L2 AND S1, AND THE SCREWS WERE SUBSEQUENTLY REVISED UNDER FLUOROSCOPY. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION ATTRIBUTED THE EVENT TO A PLATFORM SHIFT OF THE REFERENCE ASSEMBLY, LIKELY CAUSED BY INTRAOPERATIVE RETRACTOR MANIPULATION AND SUBOPTIMAL PIN SEATING. WHILE USER ERROR REMAINS THE MOST REASONABLE ASSUMPTION, A DEFINITIVE ROOT CAUSE COULD NOT BE CONCLUSIVELY CONFIRMED. AS THE SYSTEM FUNCTIONED AS INTENDED AND NO MALFUNCTION WAS IDENTIFIED, THE DECISION TO REPORT IS BASED ON THE INABILITY TO DEFINITIVELY RULE OUT THE EVENT'S POTENTIAL FOR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178232 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) SBF AUGMEDICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other