BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3092494 · Received May 3, 2013

    Report

    Report Number
    1030489-2013-01534
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8115525, 510K # K032578 WAS CLEARED IN THE UNITED STATES. 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. IT WAS REPORTED THAT THE AFTER BREAKING OFF ONE SIDE OF THE CROSSLINK SET SCREW, THE OTHER SIDE DETACHED FROM THE ROD. THE SURGEON WAS GOING TO UNSCREW THE SETSCREW USING A REMOVAL DRIVER TO RE-POSITION THE CROSSLINK, BUT THE SETSCREW HEAD WAS STRIPPED AND WAS IMPOSSIBLE TO BE UNSCREWED. AS A RESULT, THE CROSSLINK WAS REMOVED WITH THE ROD, AND NEW CONSTRUCT WAS ADDED TO THE PATIENT. THE INCIDENT CAUSED DELAY OF THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193859 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1