BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 8069199 · Received November 14, 2018

    Report

    Report Number
    3005725110-2018-00004
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 14, 2018
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COFLEX REMOVAL DUE TO IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910878 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    0 Required Intervention