BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COFLEX INTERLAMINAR TECHNOLOGY

    MDR report key: 12908901 · Received December 1, 2021

    Report

    Report Number
    3005725110-2021-00001
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    August 6, 2021
    Report Date
    December 1, 2021
    Manufacturer
    PARADIGM SPINE GMBH
    Product Code
    NQO
    UDI-DI
    0426014898532
    PMA / PMN Number
    P110008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COFLEX REVISION SURGERY : ON PREOP X-RAYS A BROKEN WING WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804451 COFLEX INTERLAMINAR TECHNOLOGY PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE GMBH UQI00014 2418313102 0426014898532

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention