BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC/SOFAMOR DANEK

    MDR report key: 3173394 · Received April 30, 2013

    Report

    Report Number
    3173394
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    May 11, 2012
    Report Date
    April 26, 2013
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE IS FRACTURE / HARDWARE FAILURE OF THE RIGHT PARASPINAL ROD OVER L5/S1 REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188850 MEDTRONIC/SOFAMOR DANEK ROD SPINAL CD HORIZON LEGACY 500MM 5.5MM NKB 869022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention