BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 17997291 · Received October 24, 2023

    Report

    Report Number
    3016571711-2023-00013
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 24, 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

    THE SURGEON WAS USING A BURR TO NAVIGATE AND BURR HIS STARTING POINTS FOR FACETECTOMIES WHEN THE BUTTON ON THE ADAPTER POPPED OUT OF THE ADAPTER. UPON TAKING AP FLUORO IMAGES THE SURGEON NOTICED A SMALL SPRING THAT MUST HAVE BELONGED TO THE ADAPTER IN THE IMAGING AND TOOK IT OUT OF THE PATIENT. THE ADAPTER WAS REMOVED FROM THE TRAY AND SENT OUT FOR FURTHER INVESTIGATION. THE INVESTIGATION CONCLUDED THAT A MALFUNCTION OF THE ADAPTER HAD OCCURRED. IT IS IMPORTANT TO CLARIFY THAT IN THIS SITUATION WHERE THE SPRING COULD HAVE BEEN LEFT IN THE PATIENT'S BODY, IT COULD THEORETICALLY RESULT IN AN UN-DESIRE TISSUE RESPONSE. THE RISK IN A TISSUE RESPONSE HAS BEEN ANALYZED AND WAS FOUND TO BE NONHAZARDOUS TO THE PATIENT'S HEALTH OVER TIME. SINCE A DEVICE MALFUNCTION HAS OCCURRED, IT WAS DECIDED TO REPORT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615695 XVISION SPINE SYSTEM (XVS) XVISION SPINE SYSTEM (XVS) OLO AUGMEDICS LTD. SWIVEL 5-6 MM UNIVERSAL TOOL ADAPTER LEG UP NA 07290113780231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other