BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3393304 · Received October 8, 2013

    Report

    Report Number
    1030489-2013-04093
    Event Type
    Injury
    Date Received
    October 8, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 9, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    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)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7643645, 510K # K040583 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 AN ANTERIOR AND POSTERIOR PROCEDURE AT T12-L2 TO TREAT A BURST FRACTURE AT L1. TWO MONTHS POST-OP IT WAS FOUND THAT THE L2 PEDICLE SCREW WAS COMING OFF. THE PATIENT WAS ASYMPTOMATIC HOWEVER THE PATIENT UNDERWENT A REVISION SURGERY 5 DAYS LATER. NO ADDITIONAL PATIENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509385 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA W06F0276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention