BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR TEHCNOLOGY

    MDR report key: 7141570 · Received December 22, 2017

    Report

    Report Number
    3005725110-2017-00008
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 22, 2017
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COFLEX IMPLANT REMOVAL. THE CAUSE OF REMOVAL WAS DUE TO REOCCURRENCE OF BACKPAIN. MRI SHOWED FLUID BETWEEN THE FACETS. THE FLUID CAN CAUSE INSTABILITY, RESULTING IN BACKPAIN COFLEX WAS REMOVED, REVISION LAMINECTOMY WAS PERFORMED AND A NEW COFLEX IMPLANT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922869 COFLEX INTERLAMINAR TEHCNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO PARADIGM SPINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention