BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX INTERLAMINAR

    MDR report key: 4217323 · Received October 24, 2014

    Report

    Report Number
    MW5038895
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 24, 2014
    Manufacturer
    PARADIGM SPINE
    Product Code
    NQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS PER THE PARADIGM SPINE MARKETING AND A RECENT RETROSPECTIVE REVIEW, I IMPLANTED A COFLEX INTERSPINOUS DYNAMIC STABILIZATION DEVICE AT L4/5 IN THE SETTING OF A STABLE GRADE I SPONDYLOLISTHESIS. THE PATIENT IMPROVED FOR 8 MONTHS. AFTER 8 MONTHS, HE BECAME UNSTABLE, HAD>4MM ON FLEXION EXTENSION VIEWS THAT WAS NO PRESENT PRE IMPLANT AND DEVELOPED WORSENING BACK AND LEG PAIN. HE NOW HAS TO BE REVISED WITH A FUSION. HE WAS 9 MONTHS OUT FROM SURGERY AND DEVELOPED THIS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679677 COFLEX INTERLAMINAR PROSTHESIS, SPINOUS PROCESS SPACER NQO PARADIGM SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR