BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 24422336 · Received February 23, 2026

    Report

    Report Number
    3012428435-2026-00059
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 23, 2026
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860012901
    PMA / PMN Number
    K212405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO REPORTS OF PATIENT NONCOMPLIANCE OR INTERVENING EVENTS WERE PROVIDED. REVIEW OF INTRAOPERATIVE LATERAL X-RAY INDICATES THE C6/7 INTERBODY DEVICE WAS POSITIONED ANTERIOR TO THE ANTERIOR CORTEX OF THE C6 VERTEBRAL BODY, AND THE PLATE WAS NOT FLUSH WITH THE C7 VERTEBRAL BODY. THE C7 SCREW TRAJECTORY MEASURED APPROXIMATELY 25 DEGREES CAUDALLY. FOLLOW-UP LATERAL X-RAY DEMONSTRATES POSTERIOR SUBSIDENCE OF THE C6/7 INTERBODY DEVICE INTO THE C6 VERTEBRAL BODY AND ANTERIOR SUBSIDENCE INTO THE C7 VERTEBRAL BODY. THE C7 SCREW TRAJECTORY ON FOLLOW-UP IMAGING APPEARS APPROXIMATELY NEUTRAL WITHIN THE VERTEBRAL BODY. THE RETURNED PLATE, COVER AND SCREWS WERE EVALUATED. NO EVIDENCE OF FRACTURE, DEFORMATION, OR MATERIAL/MANUFACTURING DEFECT WAS IDENTIFIED. THE C7 LOCKING COVER WAS OBSERVED TO BE DISENGAGED. BASED ON X-RAY REVIEW AND DEVICE EVALUATION, INTERBODY SUBSIDENCE IS CONSIDERED THE LIKELY CONTRIBUTING FACTOR TO SCREW TRANSLATION. THE CHANGE IN SCREW ORIENTATION WOULD BE EXPECTED TO INCREASE LOADING AT THE LOCKING INTERFACE, WHICH IS CONSISTENT WITH THE OBSERVED DISENGAGEMENT OF THE C7 LOCKING COVER. A MANUFACTURING OR MATERIAL DEFECT WAS NOT IDENTIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT LOT WAS REVIEWED. ALL MANUFACTURING AND ACCEPTANCE ACTIVITIES WERE COMPLETED AS REQUIRED, AND NO NONCONFORMANCES OR DEVIATIONS RELATED TO THE REPORTED EVENT WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE SURGERY OCCURRED ON (B)(6) 2025. THE DOCTOR HAD A PATIENT RECEIVE NORMAL 1-MONTH POST-OP X-RAY AS PART OF ROUTINE FOLLOW-UP. AFTER REVIEWING THE X-RAY, THE DOCTOR NOTED THE BOTTOM SCREWS WERE BACKING OUT AND THE COVER WAS DISPLACED. THE PICTURES BELOW SHOW AN X-RAY INTRAOPERATIVELY AFTER IMPLANTATION DURING THE INITIAL SURGERY (LEFT) AND AN X-RAY AT ROUTINE FOLLOW-UP (RIGHT). A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. THE PLATE AND SCREWS WERE EXPLANTED AND RETURNED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484026 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0439 00195860012901

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other| R 100-38V16, QTY. 6 SCREWS.