BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3063328 · Received April 17, 2013

    Report

    Report Number
    1030489-2013-01083
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE AT T8-L1 TO TREAT VERTEBRAL DEFORMITY WITH A HEMIVERTEBRA RESECTION AT T11. IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXTEND THE CONSTRUCT TO L2 DUE TO SCREWS LOOSENED AT T12 AND L1. IT WAS ALSO NOTICED ON X-RAY THAT THERE WAS 'A CLEAR ZONE' AROUND RIGHT L1. THE SCREWS WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166216 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1