BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON

    MDR report key: 4466466 · Received January 21, 2015

    Report

    Report Number
    MW5040477
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    February 29, 2012
    Report Date
    January 21, 2015
    Manufacturer
    OSTEOTECH
    Product Code
    MBP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, I UNDERWENT C5, C6 CERVICAL INTERBODY FUSION PERFORMED BY DR (B)(6). DEVICES UTILIZED INCLUDE: AMEDICA VALEO CERVICAL CAGE (2) PACKED WITH (IN COMBINATION WITH) OSTEOTECH GRAFTON PUTTY. VALEO IS ONLY CLEARED FOR ONE-LEVEL CERVICAL INTERBODY FUSION. GRAFTON NOT APPROVED OR CLEARED TO BE USE FOR INTENDED USES IN CERVICAL SPINE OR FOR INDICATIONS REQUIRING LOAD BEARING, STABILITY OF BONEY STRUCTURES. THE SURGEON, DR (B)(6) FAILED TO DISCLOSE THAT DEVICES WOULD BE USED IN MANNER NOT APPROVED OR CLEARED BY FDA OR THAT HE HAD FINANCIAL TIES TO MEDTRONIC, PARENT COMPANY OF OSTEOTECH. POST-OP COMPLICATIONS INCLUDE BUT NOT LIMITED TO, WORSENING OF PRE-OP SYMPTOMS, DYSPHAGIA, DYSPHONIA, TUMOR AND BONEY OVERGROWTH. REVISION POSTERIOR CERVICAL FUSION PERFORMED ON (B)(6) 2014 BY DR (B)(6), WHO ALSO DID NOT DISCLOSE CONFLICT WITH MEDTRONIC. I AM RENDERED FULLY DISABLED AND IN CONSTANT PAIN. HAVE BEEN RECOMMENDED FOR SPINAL STIMULATOR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50808 GRAFTON GRAFTON MBP OSTEOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| O| R| S