BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3010601 · Received March 19, 2013

    Report

    Report Number
    1030489-2013-00780
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K052187
    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 SURGICAL PROCEDURE TO EXTEND THE ORIGINAL CONSTRUCT FROM T10-L2 TO T7-L4 TO TREAT INTER VERTEBRAL DISEASE. IT WAS REPORTED THAT THE SURGEON COULD NOT BREAK OFF THE SETSCREW HEAD AT RIGHT L3 AND L4. THE SURGEON USED A BUR TO CUT OFF THE BREAK OFF PORTION. OTHER SETSCREWS BREAK-OFF PORTION HAD BEEN REMOVED WITHOUT ANY INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113458 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR