BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3800320 · Received May 8, 2014

    Report

    Report Number
    1030489-2014-02448
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    May 12, 2011
    Report Date
    April 9, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    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 FUSION AT T8-S1 TO TREAT KYPHOSCOLIOSIS. THE PATIENT UNDERWENT A REVISION SURGERY ONE MONTH POST-OP DUE TO SCREW LOOSENING. THE CONSTRUCT WAS ALSO EXTENDED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277469 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS, SCREWS, SET SCREWS