BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 17749797 · Received September 14, 2023

    Report

    Report Number
    3012428435-2023-00030
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 14, 2023
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860012741
    PMA / PMN Number
    K212405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN APPROXIMATION WAS MADE TO COMPARE THE 3D MODEL TO THE X-RAY IMAGE. FROM THIS ANALYSIS IT LOOKS LIKE THE BOTTOM SCREWS WERE OVERANGULATED BY ABOUT 5° PAST THE MAXIMUM ALLOWABLE SCREW ANGLE.ALSO, IT IS POSSIBLE TO SEE THE EDGE OF THE SCREW STICKING SLIGHTLY ABOVE THE PLATE PROFILE (CIRCLED BELOW), WHICH IS ANOTHER INDICATOR THAT THE SCREW WAS INSERTED BEYOND THE MAXIMUM ALLOWABLE ANGLE. WHEN SCREWS ARE INSERTED OVER ANGLED THEY PUT MORE PRESSURE ON THE COVER PLATE.IN ADDITION, IT IS NOTABLE THAT ALL OF THE CAGES ARE CONTACTING THE PLATE. IF THE CAGES MOVE THEY COULD PUT ADDITIONAL PRESSURE ON THE PLATE AND SCREWS.THIS EVENT MAY HAVE OCCURRED DUE TO OVER ANGULATING THE LOWER SCREWS LEADING TO EXCESSIVE FORCE ON THE COVER. HOWEVER, SINCE THE DEVICES HAVE NOT BEEN RETURNED FOR FURTHER ANALYSIS, THE EXACT CAUSE OF THE SCREW BACKOUT IS UNKNOWN.

    Description of Event or Problem · 0

    THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. ON (B)(6) 2023, A PATIENT VISITED ON A ROUTINE FOLLOW-UP APPOINTMENT. AFTER REVIEWING THE X-RAY ON (B)(6) 2023, THE LATERAL IMAGES ABOVE SHOW THAT BETWEEN THE IMMEDIATE POST-OP AND FOLLOW UP X-RAY THAT THE 2 SCREWS PLACED IN C5 HAD BACKED OUT AND THE COVER PLATE IS FLOATING ABOVE THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362412 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0387 00195860012741

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Prefer Not To Disclose Other 100-38V16, QTY 4, DIA 3.75X16MM SCREW