BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 15889923 · Received November 30, 2022

    Report

    Report Number
    3012428435-2022-00028
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    October 30, 2022
    Report Date
    November 30, 2022
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860012895
    PMA / PMN Number
    K220275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRIMARY SURGERY WAS (B)(6) 2022 AND THE X-RAYS ARE FROM (B)(6) 2022 (20 DAYS SINCE PRIMARY SURGERY), THERE IS NO EXPECTATION THAT ANY FUSION AS OCCURRED. EVOLUTION WAS NOT PROVIDED WITH IMMEDIATE POST-OP X-RAYS, SO WE DO NOT KNOW THE ORIGINAL POSITION OF THE PLATE AND SCREWS, HOWEVER IT WAS NOTED THAT THE PLATE WAS NOT ALIGNED PERFECTLY VERTICAL ON THE SPINE AND THE CEPHALAD SCREWS (C3) ARE CENTERED BUT THE MOST CAUDAL LEVEL IS POSITIONED VERY SLIGHTLY TO THE RIGHT OF MIDLINE. IN ADDITION, IT LOOKS LIKE THE RIGHT SCREW IN C5 IS ANGLED MEDIALLY, POTENTIALLY MORE THAN THE MAXIMUM ALLOWABLE SEEN IN THE EMERGE PLATES; HOWEVER, WITHOUT AN IMMEDIATE POST-OP X-RAY IT IS UNKNOWN WHETHER THIS SCREW WAS PLACED IN THE ORIENTATION DURING THE PRIMARY PROCEDURE, OR IT MOVED DURING THE 20 DAYS BETWEEN THE PRIMARY SURGERY AND THE X-RAYS TAKEN ON (B)(6) 2022. IN LOOKING AT THE LATERAL VIEW, IT LOOKS LIKE BONE WAS USED AS AN INTERBODY. BONE TENDS TO PLACE MORE STRESS ON THE PLATE THAN AN INTERBODY CAGE BECAUSE BONE DOES NOT MAINTAIN THE SAME DISC HEIGHT AS A CAGE. BONE BEGINS TO RESORB OVER TIME AND LOSES UP TO 10% OF ITS HEIGHT IN THE PROCESS. THE MOST CAUDAL LEVEL (C5 IN THIS CASE) TYPICALLY HAS THE HIGHEST STRESS ON THE SCREWS WHEN COMPARED TO THE HIGHER LEVELS (C3 AND C4 IN THIS CASE). THE CAUDAL SCREWS TYPICALLY START IN AN ANGULATED POSITION BUT THEN MAY END UP IN A NEUTRAL OR CEPHALAD ANGULATION AS THE VERTEBRAL BODIES SETTLE AND THE WEIGHT OF THE HEAD PUTS DOWNWARD FORCE ON THE PLATE CONSTRUCT. WITHOUT IMMEDIATE POST-OP X-RAYS WE DO NOT KNOW IF THE ANGLE OF THE SCREW HAS SHIFTED. SHIFTING SCREWS COULD PUT ADDITIONAL LOADS ON THE COVER PLATE THAT COULD CONTRIBUTE TO THE COVER SEPARATING FROM THE PLATE. IN ADDITION, IT LOOKS LIKE THE PLATE MAY BE JUST SLIGHTLY PROUD OFF THE BONE. THE CENTER SCREWS LOOK TO BE VERY CLOSE TO THE CAUDAL ENDPLATE OF THE C4 VERTEBRAL BODY. IT IS UNCLEAR IF THE ENDPLATE WAS COMPROMISED. THE RIGHT C5 SCREW IDENTIFIED ON THE ANTERIOR X-RAY THAT IS IN A HIGHLY ANGLED MEDIAL POSITION DOES NOT APPEAR TO BE HIGHLY ANGLED CEPHALAD OR CAUDAL ON THIS FOLLOW UP X-RAY. THE HEAD CAN BE SEEN SLIGHTLY ABOVE THE PLATE, BUT IT DOES NOT APPEAR THAT THE SCREW HAS MIGRATED OUT OF THE VERTEBRAL BODY AT THIS TIME. THE COVER CAN BE SEEN SEPARATED FROM THE PLATE 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. 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.

    Description of Event or Problem · 0

    AN EMERGE PLATE WAS IMPLANTED ON (B)(6) 2022. DURING THE POST-OP VISIT IT WAS NOTED THAT THE BOTTOM LOCKING COVER WAS "DISLODGED" FROM THE PLATE AND ONE OF THE BOTTOM SCREWS APPEARS TO HAVE STARTED TO DISLODGE FROM THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2696027 EMERGE ANTERIOR CERVICAL PLATE SYSTEM ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 100-2L40 0101 00195860012895

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention 100-38F12, FIXED SCREW DIA 3.75 X 12 MM, QTY 2| 100-38F14, FIXED SCREW DIA 3.75 X 14 MM, QTY 4| 100-A008 CERVICAL DRILL, 12MM, QTY 1| 100-A024, TEMPORARY PIN, QTY 1