BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWS

    MDR report key: 5440756 · Received February 17, 2016

    Report

    Report Number
    5440756
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 22, 2016
    Report Date
    February 9, 2016
    Manufacturer
    AMENDIA, INC.
    Product Code
    MRW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS ADMITTED EARLY THIS YEAR WITH COMPLAINTS OF LOWER LEFT LEG PAIN AND LOWER BACK PAIN. THE PATIENT HAD A PREVIOUS L4-S1 FUSION. THE WORK UP REVEALED BILATERAL BROKEN SCREWS AT S1 AND THE CAGE MIGRATED IN THE CANAL WITH SEVERE FORAMINAL STENOSIS. THE PATIENT WAS TAKEN TO SURGERY FOR REVISION AND REMOVAL AND REPLACEMENT OF THE SCREWS. THE PATIENT DID WELL POSTOPERATIVELY AND WAS DISCHARGED A FEW DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98421 SCREWS SYSTEM, FACET SCREW SPINAL DEVICE MRW AMENDIA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other