BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVIEW S1

    MDR report key: 15118045 · Received July 27, 2022

    Report

    Report Number
    3016619943-2022-00001
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    June 7, 2022
    Report Date
    July 7, 2022
    Manufacturer
    NVIEW MEDICAL
    Product Code
    OWB
    PMA / PMN Number
    K211064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANIES PRODUCTION WEBTRADER ACCOUNT TOOK 24 DAYS TO CREATE DUE TO OUR FEI NOT BEING INCLUDED IN THE TEST DATABASE. THIS RESULTED IN A DELAYED FILING OF THIS FIRST MDR. THE HELP TICKET IS INCLUDED AS AN ATTACHMENT.

    Description of Event or Problem · 0

    DURING AN ADOLESCENT SCOLIOSIS PROCEDURE DONE ON T4-L3, THE NAVIGATION OF THE NVIEW S1 WAS INACCURATE. THE SURGEON HAD TO CORRECT 3 OUT OF 18 SCREWS (T4 LEFT, T5 LEFT, T6 LEFT) DURING THE PROCEDURE. THE SCREW MISPOSITIONS WERE IDENTIFIED IN THE VERIFICATION IMAGE TAKEN BY THE NVIEW S1. T4 LEFT WAS REPLACED WITH A HOOK AND T5 LEFT AND T6 LEFT WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2922874 NVIEW S1 MOBILE FLUOROSCOPIC C-ARM, OWB NVIEW MEDICAL S1 WITH NAV OPTION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male