BEUDAMED
    FDA Adverse Event Summary report: N

    COFLEX (R) INTERLAMINAR TECHNOLOGY

    MDR report key: 4347513 · Received December 10, 2014

    Report

    Report Number
    3005725110-2014-00008
    Date Received
    December 10, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 10, 2014
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COFLEX EXPLANTATION DUE TO IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797297 COFLEX (R) INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH UQI00008 2013004148

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention