BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 17749211 · Received September 14, 2023

    Report

    Report Number
    3012428435-2023-00029
    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
    00195860013052
    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

    A HIGHLY MEDIALIZED SCREW COULD PUT ADDITIONAL LOADS ON THE COVER PLATE THAT COULD CONTRIBUTE TO THE COVER SEPARATING FROM THE PLATE. THE POSITION OF THE SCREWS WAS SIMULATED USING THE 3D CAD MODEL. THE SCREWS WERE PLACED IN A SIMILAR MANNER TO THE ANTERIOR X-RAY, AND THE PLATE AND COVER WERE MADE TO BE TRANSPARENT TO SIMULATE THE X-RAY. THE 3D CAD LOOKS TO BE A REASONABLE FACIMILE OF THE POSITION OF THE SCREWS. WHEN ROTATING THE 3D CAD MODEL, IT SHOWS THAT WHEN THE SCREW IS MEDIALIZED AS MUCH AS IS SHOWN IN THE X-RAY, THE SCREW HEAD INTERFERES WITH THE COVER. IF THE SCREW WAS PLACED IN THE SAME MEDIAL ORIENTATION AS SHOWN IN THE CAD MODEL DURING THE PRIMARY PROCEDURE, THEN IT WOULD HAVE BEEN VERY DIFFICULT TO LOCK THE COVER. IF THE COVER WAS OVERPOWERED, THEN IT COULD PULL THE COVER UP AND OUT OF THE PLATE. THE SURGEON MAY OR MAY NOT BE AWARE THAT THE COVER WAS COMPROMISED IN THIS SITUATION. THE ANGULATION OF THE RIGHT SCREW APPEARS TO BE BEYOND THE ANGULATION LIMITS. 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 MEDIALIZING THE LOWER SCREW 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 08/23/2024, THE LATERAL IMAGES ABOVE SHOW THAT BETWEEN THE IMMEDIATE POST-OP AND FOLLOW UP X-RAY THAT THE 2 SCREWS PLACED IN C7 HAD BACKED OUT AND THE COVER PLATE IS FLOATING NEXT TO THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391220 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0117 00195860013052

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other 100-38V16, QTY 2, SCREW DIA 3.75 X 16 MM| 100-38V18, QTY 4, SCREW DIA 3.75 X 18 MM| 100-43V18, QTY 4, SCREW DIA 4.25 X 18 MM