BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4223201 · Received November 4, 2014

    Report

    Report Number
    1030489-2014-04200
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 6, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 WITH GROWTH RODS AT T2-L3 TO TREAT SCOLIOSIS. THE PATIENT UNDERWENT AN EXTENSION PROCEDURE 6 MONTHS LATER. FIVE MONTHS POST-OP, IT WAS FOUND THAT THE LEFT ROD WAS BROKEN AT T11-12 AND THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN ROD AND DOMINO. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705552 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention