BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIO PLATE AND SCREWS

    MDR report key: 6010507 · Received October 5, 2016

    Report

    Report Number
    MW5065230
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 26, 2016
    Manufacturer
    DIO MEDICAL
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CERVICAL SPONDYLOSIS WITH RADICULOPATHY AND FAILURE OF PREVIOUS HARDWARE. REMOVAL C3 THROUGH C6 ANTERIOR PLATE DUE TO LOOSENING OF SCREWS AND PROTRUDING OUT OF BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651028 DIO PLATE AND SCREWS DIO PLATE AND SCREWS MNH DIO MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R