BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 17602830 · Received August 23, 2023

    Report

    Report Number
    3012428435-2023-00027
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 22, 2023
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    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

    THIS EVENT OCCURRED DUE TO SUBSIDENCE OF THE INTERBODY LEADING TO EXCESSIVE FORCE ON THE SCREWS. IN ADDITION, DR BELIEVED THAT THE PATIENT RECEIVING A STEROID INJECTION MAY HAVE ALSO COMPLICATED THE SITUATION. IMPROVEMENTS TO THE STRENGTH OF THE COVER ARE IN PROCESS TO TRY AND REDUCE THE PROBABILITY OF THE COVER COMING OFF IN THE FUTURE. THE PRIMARY FAILURE OF THIS DEVICE WAS MOST LIKELY DUE TO SUBSIDENCE OF THE INTERBODY; HOWEVER, THE STRENGTH OF THE COVER COULD HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. ON (B)(6) 2023, A PATIENT VISITED DR COMPLAINING OF PAIN AND DYSPHAGIA. DR ORDERED AN X-RAY. AFTER REVIEWING THE X-RAY ON (B)(6) 2023, DR SCHEDULED A REVISION SURGERY FOR (B)(6) 2023. AFTER REVIEW OF THE X-RAY DR NOTED THAT THE 2 SCREWS PLACED IN C7 HAD BACKED OUT. THE X-RAY ALSO SHOWS THE COVER SITTING PROUD. IN ADDITION, DR NOTED THAT THE C6/C7 INTERBODY HAD SUBSIDED INTO THE C7 ENDPLATE. DR ALSO MENTIONED THAT THE INTERBODIES WERE FUSED, SO HE REMOVED THE BOTTOM TWO SCREWS AND COVER AND LEFT THE REST OF THE PLATE IN THE PATIENT. DR NOTED THAT THE PATIENT HAD RECEIVED STEROID INJECTIONS AFTER THE PROCEDURE WITHOUT HIS KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138629 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention 100-38V16, QTY 2, 3.75MM X 18MM SCREW| 100-38V16, QTY 4, 3.75MM X 16MM SCREW