BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 19264366 · Received May 7, 2024

    Report

    Report Number
    3012428435-2024-00036
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 7, 2024
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860012888
    PMA / PMN Number
    K212405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, BUT WITH MISSING COMPONENTS. THE EXACT CAUSE OF THE ISSUE IS UNKNOWN.

    Description of Event or Problem · 0

    THE SURGEON WAS PRE-PLANNING A REVISION IN ORDER TO EXTEND AN OLDER CONSTRUCT BY 2 LEVELS DUE TO ADJACENT SEGMENT DISEASE. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2022. THERE WAS NO MENTION OF SCREW BACKOUT FROM THE SURGEON. A REVIEW OF THE X-RAY IT WAS OBSERVED THAT THE BOTTOM SCREW WAS BACKING OUT AND THE COVER HAD DISPLACED. SURGEON DID NOT REVISE BECAUSE OF THE BACKOUT, BUT BECAUSE OF THE ADJACENT SEGMENT DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621738 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0100 00195860012888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other 100-38V16, QTY 2, SCREWS| 100-38V18, QTY 4, SCREWS