BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 18959686 · Received March 22, 2024

    Report

    Report Number
    3012428435-2024-00034
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 22, 2024
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860013144
    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

    THE SCREW APPEARS TO BE AT A HIGH ANGULATION AT THE TOP AND BOTTOM OF THE CONSTRUCTS, WHICH WE HAVE SEEN IN THE PAST COULD CONTRIBUTE TO COVER BACKOUT. BETWEEN THE 3 MONTH AND 12-MONTH X-RAYS IT DOES APPEAR THAT THE TOP AND BOTTOM SCREWS HAVE ALSO TRANSLATED, POTENTIALLY DUE TO SETTLING OF THE INTERBODY CAGES, THAT CAN ALSO LEAD TO ADDITIONAL STRESS ON THE COVERS. SINCE THE DEVICES HAVE NOT BEEN RETURNED FOR FURTHER ANALYSIS, THE EXACT CAUSE OF THE COVER BACKOUT IS UNKNOWN.

    Description of Event or Problem · 0

    THE PRIMARY SURGERY OCCURRED ON (B)(6) 2022. DR HAD A PATIENT RECEIVE NORMAL POST-OP X-RAYS DURING ROUTINE FOLLOW-UP (THE FOLLOW-UP OCCURRED 15 MONTHS AFTER PRIMARY SURGERY). AFTER REVIEWING THE X-RAY DR NOTED THAT THE TOP LOCKING CAP HAD DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360732 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0463 00195860013144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other 100-38VT14, QTY 1, SCREWS| 100-38VT16, QTY 9, SCREWS