BEUDAMED
    FDA Adverse Event Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 3809690 · Received April 25, 2014

    Report

    Report Number
    3005725110-2014-00003
    Date Received
    April 25, 2014
    Date of Event
    February 6, 2014
    Report Date
    April 24, 2014
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COFLEX REMOVAL DUE TO DISCOGENIC PAIN AND INSTABILITY WHICH REQUIRED FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250748 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH UAI00016 2005002585

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention