BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3262266 · Received August 2, 2013

    Report

    Report Number
    1030489-2013-03182
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6950315, 510K # K042498 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT H13A5576 IS 02/14/2013; MANUFACTURE DATE FOR LOT H13A6298 IS 02/16/2013; MANUFACTURE DATE FOR LOT H13A6299 IS 02/20/2013; MANUFACTURE DATE FOR LOT H13B0854 IS 02/17/2013; MANUFACTURE DATE FOR LOT H13B3156 IS 03/09/2013; MANUFACTURE DATE FOR LOT H13B3157 IS 03/05/2013; MANUFACTURE DATE FOR LOT H13C2140 IS 04/09/2013. 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 OCCIPITAL- T2. IT WAS REPORTED THAT THE SET SCREW ON THE RIGHT SIDE BACKED OUT AND THE SETSCREW ON THE LEFT SIDE LOOSED. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SET SCREWS. A CROSSLINK WAS ALSO ADDED TO THE CONSTRUCT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361943 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention ROD, PLATE, SCREW