BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE

    MDR report key: 1961022 · Received January 10, 2011

    Report

    Report Number
    MW5018966
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 26, 2008
    Report Date
    January 10, 2011
    Manufacturer
    NUVASIVE
    Product Code
    NKB
    Report Source
    Voluntary report
    Reporter Location
    GU, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A XLIF SPINE FUSION OF L4/L5 ON THE (B)(6) 2008 AT THE (B)(6). I HAVE JUST LOOKED AT THE FDA MEDICAL DEVICE APPROVAL LETTER FOR THE NUVASIVE IMPLANT INSERTED INTO MY SPINE AND REALIZED THE SURGEON FAILED TO USE FIXATION ON MY SPINE. THE FDA ONLY APPROVED THE DISC CAGE IMPLANT IF ADDITIONAL FIXATION IS USED AS WELL. THIS APPEARS ON THE MANUFACTURER'S FDA APPROVAL LETTER REQUEST BELOW: WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF4/K043405.PDF, WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF5/K052210.PDF. (B)(6). THERE'S NOTHING HOLDING ME TOGETHER. UNKNOWN WHAT MATERIALS WERE USED AS BONE GROWTH DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE COROENT CAGE IMPLANT NKB NUVASIVE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention