BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 23694216 · Received December 2, 2025

    Report

    Report Number
    3016571711-2025-00028
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    July 26, 2023
    Report Date
    December 2, 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

    THE COMPANY WAS RECENTLY NOTIFIED ABOUT AN ADVERSE EVENT THAT OCCURRED DURING A PROCEDURE UTILIZING THE XVISION SYSTEM. THE CASE REPORT DID NOT SHOW THAT AN ADVERSE EVENT OCCURRED AT THE TIME, OR THAT THERE WAS A MALFUNCTION WITH THE XVISION SYSTEM. THE COMPANY DOES NOT HAVE ANY INFORMATION SHOWING THAT THE XVISION SYSTEM WAS A FACTOR IN THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913392 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability