BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE ANTERIOR CERVICAL PLATE

    MDR report key: 18470274 · Received January 8, 2024

    Report

    Report Number
    3012428435-2023-00031
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    June 27, 2023
    Report Date
    January 8, 2023
    Manufacturer
    EVOLUTION SPINE LLC
    Product Code
    KWQ
    UDI-DI
    00195860013137
    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 MAY HAVE OCCURRED DUE TO OVER ANGULATING THE LOWER SCREWS LEADING TO EXCESSIVE FORCE ON THE COVER. HOWEVER, SINCE THE DEVICES HAVE NOT BEEN RETURNED FOR FURTHER ANALYSIS, THE EXACT CAUSE OF THE SCREW BACKOUT IS UNKNOWN.

    Description of Event or Problem · 0

    THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. EVOLUTION WAS CONDUCTING A CADAVER LAB WITH THE DOCTOR (ON AN UNRELATED PROJECT) ON (B)(6) 2023 (DATE OF AWARENESS) AND HE MENTIONED THAT HE HAD A COVER COME OFF OF AN EMERGE PLATE. THE DOCTOR DID NOT PROVIDE ANY IMAGES OR ADDITIONAL DETAILS OTHER THAN THAT THE LOWEST PLATE COVER WAS SHOWN AS DISPLACED ON A ROUTINE FOLLOW-UP X-RAY. THE DOCTOR SAID THAT THE PATIENT IS FUSED, AND NO REVISION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461981 EMERGE ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ EVOLUTION SPINE LLC 0462 00195860013137

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Prefer Not To Disclose Other 100-38VT14, QTY 2 - VARIABLE CERVICAL SCREW| 100-43VT12, QTY 1 - VARIABLE CERVICAL SCREW| 100-43VT14, QTY 5 - VARIABLE CERVICAL SCREW