BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 18389933 · Received December 24, 2023

    Report

    Report Number
    3016571711-2023-00017
    Event Type
    Malfunction
    Date Received
    December 24, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 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

    A BURR WAS BEING NAVIGATED WITH A 5-6MM UNIVERSAL SWIVEL ADAPTER ATTACHED. ABOUT AN HOUR INTO NAVIGATION, THE SCRUB TECH INFORMED THE REP THAT HE PLACED THE DRILL DOWN ON THE MAYO STAND. WHEN HE WENT TO PICK IT BACK UP FROM THE MAYO, THE TRIGGER WAS LOOSE AND CAME OUT. THE SCRUB SET THE TRIGGER AND THE INTERNAL SPRING ASIDE, AND THE ADAPTER WAS REPLACED WITH ANOTHER FOR THE REST OF THE CASE. NO HARM TO THE PATIENT HAD OCCURRED DURING THE PROCEDURE. 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
    2307494 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