BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUELOCK

    MDR report key: 872219 · Received March 12, 2007

    Report

    Report Number
    2242816-2007-00009
    Event Type
    Malfunction
    Date Received
    March 12, 2007
    Date of Event
    February 5, 2007
    Report Date
    March 2, 2007
    Manufacturer
    EBI
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BROKEN SCREWS AT C4 (TOP RIGHT SCREW) WAS OBSERVED TWO YEARS AFTER INITIAL SURGERY. PATIENT OUTCOME: PATIENT IS TWO YEARS OUT AND SOLIDLY FUSED. APPEARS TO BE SETTLING THE PLATE AND THE TOP SCREWS ARE AT A STEEP ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUELOCK KWQ KWQ EBI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *