BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK TITANIUM INTERBODY IMPLANTS SIZE 12 5.5X60MM

    MDR report key: 5849515 · Received August 3, 2016

    Report

    Report Number
    MW5063837
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    April 14, 2014
    Report Date
    July 22, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DR (B)(6) PUT ME TO SLEEP AND DID A SURGERY ON ME, USING PEEK TITANIUM INTERBODY IMPLANTS WITH GRAFTING ON NUVASIVE LATERAL VERTEBRAL BODY PLATES XLIFT WITHOUT DISCUSSING NY F THIS PROCEDURE WITH ME. IT FAILED HORRIBLY. HE ATTEMPTED TO FIX IT IN (B)(6) 2014 AND DID NOT REMOVE THE NUVASIVE OR PEEK FAILED DEVICES AND THIS PROBLEM HAS CONTINUED TO GET WORSE. REASON FOR USE: RUPTURED DISC IN MY BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496867 PEEK TITANIUM INTERBODY IMPLANTS SIZE 12 5.5X60MM PEEK TITANIUM INTERBODY IMPLANTS ODP MEDTRONIC SOFAMOR DANEK 7145560
    497011 XLIFT 10 ML NUVASIVE LATERAL VERTEBRAL BODY PLATES KWQ NUVASIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability