BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 3070664 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01176
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 24, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). EVENT LOCATION OTHER : UNK. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 75445540, 510K # K042025 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 LUMBAR SPINAL PROCEDURE TO TREAT LUMBAR SPINAL CANAL STENOSIS AT L4-5. APPROXIMATELY TWO YEARS POST-OP THE PATIENT UNDERWENT A SECOND SURGERY DUE TO ADJACENT LEVEL DISEASE AND THE CONSTRUCT WAS EXTENDED TO L3. 21 DAYS POST-OP IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SCREW LOOSENING AT L3 AND THE RIGHT SIDE SCREW AT L5 PERFORATED THE VERTEBRAL BODY TOWARDS THE SPINAL CANAL. THE COMPLAINT SCREWS WERE REMOVED AND REPLACED. THE SURGEON COMMENTED THAT THE PATIENT'S BONE WAS POOR. THE PATIENT IS ALSO SUFFERING OF LOWER EXTREMITY PARALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172640 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Disability