BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX

    MDR report key: 5553836 · Received April 4, 2016

    Report

    Report Number
    MW5061525
    Event Type
    Injury
    Date Received
    April 4, 2016
    Date of Event
    April 4, 2016
    Report Date
    April 4, 2016
    Manufacturer
    PARADIGM SPINE
    Product Code
    NQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT'S SPINE DETERIORATED AROUND COFLEX IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202200 COFLEX SPINE PROTHESIS NQO PARADIGM SPINE UQI00012 2014001827

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention