BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVISION SPINE SYSTEM (XVS)

    MDR report key: 10446961 · Received August 25, 2020

    Report

    Report Number
    3016571711-2020-00001
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 28, 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 EVENT IS RELATED TO THE PROCEDURE PERFORMED ON (B)(6) 2020. THE SURGEON REPORTED THAT 3 OF THE SCREWS DEVIATED IN POSITION. THE FIRST SCREW INSERTED WAS ACCURATE. DURING THE INVESTIGATION IT WAS FOUND OUT THE SURGEON WAS WORKING THOUGH SMALL INCISION IN OPEN PROCEDURE WHICH CAUSED FOR CONSTANT REARRANGEMENTS OF RETRACTORS AND INSTRUMENTATION HANDLING IN CLOSE VICINITY OF THE CLAMP. THE AUGMEDICS REPRESENTATIVE SUSPECTS THAT THE CLAMP CLOSING SCREW WAS NOT FULLY TIGHTNENED. IT WAS CONCLUDED THAT THE CLAMP WAS NOT TIGHTEN ENOUGH BY THE SURGEON AND THEREFORE WAS MOVED BY THE HANDLING OF THE RETRACTOR OR INSTRUMENTATION THE 3 SCREWS WERE REMOVED AND REPLACED USING FLUORO. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THE SURGEON WAS RE-TRAINED ON INDICATION FOR FULLY CLOSED CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914862 XVISION SPINE SYSTEM (XVS) NAVIGATION SYSTEM WITH AUGMENTED REALITY OLO AUGMEDICS LTD AMCH00005 07290113780002

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention