BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALCON ACP

    MDR report key: 6431492 · Received March 24, 2017

    Report

    Report Number
    6431492
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 17, 2017
    Manufacturer
    CHOICE SPINE LP
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANTED SCREWS AND PLATE WERE REMOVED DUE TO PATIENT FALL AND LACK OF FUSION RESULTING IN BROKEN SCREW. PLATE AND ALL SCREWS WERE REMOVED EXCEPTING THE PORTION OF THE BROKEN SCREW THAT WAS LEFT IN THE PEDICLE OF C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212985 FALCON ACP APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ CHOICE SPINE LP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR