BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 10446962 · Received August 25, 2020

    Report

    Report Number
    3016571711-2020-00002
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    AUGMEDICS LTD
    Product Code
    OLO
    UDI-DI
    07290113780002
    PMA / PMN Number
    K190929
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MOVEMENT OF THE CLAMP MAY CAUSE FOR INACCURATE REGISTRATION AND OR DISPLAY OF TRACKING INFORMATION, WHICH MAY LEAD TO SERIOUS INJURY. THE DISLOCATION OF THE CLAMP BY MUSCLE AND FASCIA WAS EVIDENT, HENCE, THE SURGEON PLACED THE CLAMP AGAIN AND REPEATED THE SCAN. IT IS SUSPECTED THAT THE CLAMP WAS NOT CLOSED AS REQUIRED. AUGMEDICS' PERSONNEL REVIEWED THE INSTRUCTIONS AND INDICATIONS OF COMPLETE CLAMP CLOSURE AGAIN WITH THE SURGEON. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914863 XVISION SPINE SYSTEM (XVS) NAVIGATION SYSTEM WITH AUGMENTED REALITY OLO AUGMEDICS LTD AMCH00005 07290113780002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other