BEUDAMED
    FDA Adverse Event Summary report: N

    COFLEX INTERLAMINAR TECHOLOGY

    MDR report key: 4290278 · Received November 26, 2014

    Report

    Report Number
    3005725110-2014-00007
    Date Received
    November 26, 2014
    Report Date
    November 21, 2014
    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

    A PREVIOUSLY STABLE GRADE 1 L4/5 SPONDY TURNED INTO AN UNSTABLE ONE. MR IMAGING SHOWED FACET JOINT CYST. PT REQUIRES FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769895 COFLEX INTERLAMINAR TECHOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention