BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON LEGACY SPINAL SYSTEM

    MDR report key: 3162016 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02149
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT T11-L3 TO TREAT A BURST FRACTURE AT L1. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS POST-OPERATIVELY. A REVISION SURGERY WAS PERFORMED FOR ADDITIONAL DECOMPRESSION AND ROD BENDING. THE SURGEON COMMENTED THAT THE INCIDENT WAS DUE TO INSUFFICIENT DECOMPRESSION AND OVERCORRECTION. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262841 CD HORIZON LEGACY SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1