BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACF SPACER 9MM PARALLEL

    MDR report key: 2973932 · Received February 14, 2013

    Report

    Report Number
    MW5029043
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 24, 2012
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD CERVICAL STENOSIS. ACDF C4-C6. IT SEEMS THAT I AM ALLERGIC TO THE METAL IN THE HARDWARE THAT WAS USED TO ALLOW MY SPINE TO FUSE AFTER SURGERY. I CONTINUE TO HAVE EXCESSIVE AND DISABLING PAIN THROUGHOUT MY BODY. I AM TRYING TO FIND OUT THE COMPLETE LIST OF METALS THAT ARE IN THE MEDTRONIC MUSCULOSKELETAL TRANSPLANT FOUNDATION THAT WAS USED IN THE SURGERY. THE ITEM NUMBERS WERE 017109, (B)(4) DESC: ACF SPACER, PARALLEL, 9MM., 017109, (B)(4) DESC: ACF SPACER 9MM PARALLEL. PLEASE PROVIDE ME WITH THIS INFO OR DIRECT ME TO WHERE I CAN GET IT. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66182 ACF SPACER 9MM PARALLEL ACF SPACER PARALLEL MQP MEDTRONIC 017109
    66239 ACF SPACER 9MM PARALLEL ACF SPACER PARALLEL ODP MEDTRONIC 017109
    66240 PLATE VENTURE PLATE KWQ MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R| S