BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERIVCAL PLATE SYSTEM

    MDR report key: 17396826 · Received July 26, 2023

    Report

    Report Number
    3012428435-2023-00025
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 26, 2023
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860013137
    PMA / PMN Number
    K212405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON ADMITTED THAT HE KNOWINGLY PLACED THE EMERGE SCREWS AT AN ANGULATION THAT WAS BEYOND THE LIMITS OF THE SYSTEM, WHICH CONTRIBUTED TO THE COVER DISLODGING.THE SURGEON ALSO ADMITTED THAT HE KNOWINGLY DID NOT REPLACE THE EMERGE PLATE AFTER THE COVER HAD BEEN DAMAGED.

    Description of Event or Problem · 0

    AN EMERGE COVER DISLODGED FROM THE PLATE AFTER THE SURGEON ATTEMPTED TO TURN THE COVER PAST A SCREW THAT WAS BEYOND THE ACCEPTABLE ANGLE. THE SCREW HEAD WAS TOO PROUD AND LED TO THE COVER DISLODGING. THE SURGEON THEN SIMPLY PLACED THE DISLODGED COVER BACK INTO THE PLATE AND CLOSED THE PATIENT. SINCE THE COVER WAS DISLODGED, THE STRENGTH OF THE COVER HAS BEEN COMPROMISED AND MAY INCREASE THE PROBABILITY OF OCCURRENCE OF SCREW BACKOUT. THE SURGEON SHOULD HAVE REPLACED THE PLATE WITH A NEW PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910203 EMERGE ANTERIOR CERIVCAL PLATE SYSTEM ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 100-4L66 00195860013137

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other 100-38VT14, QTY 4 - SCREW DIA 3.75 X 14MM| 100-38VT16, QTY 6 - SCREW DIA 3.75 X 16 MM