BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 19264350 · Received May 7, 2024

    Report

    Report Number
    3012428435-2024-00035
    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
    00195860013021
    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

    SINCE THE DEVICES HAVE NOT BEEN RETURNED FOR FURTHER ANALYSIS AND NO X-RAYS WERE PROVIDED, THE EXACT CAUSE OF THE COVER BACKOUT IS UNKNOWN.

    Description of Event or Problem · 0

    THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2024. DR HAD A PATIENT RECEIVE NORMAL 1-MONTH POST-OP X-RAYS DURING ROUTINE FOLLOW-UP. AFTER REVIEWING THE X-RAY DR NOTED THAT THE BOTTOM SCREWS WERE BACKING OUT. DR THEN PERFORMED A REVISION ON (B)(6) 2024 TO REMOVE THE PLATE. THE HOSPITAL DISPOSED OF THE PLATE. NO X-RAYS WERE PROVIDED. NO IMAGES OF THE PLATE, COVERPLATE, OR SCREWS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531215 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0451 00195860013021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other 100-38V14, QTY 2, SCREWS| 100-38V16, QTY 6, SCREWS