BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6783852 · Received August 10, 2017

    Report

    Report Number
    1030489-2017-01903
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    July 19, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1606200500, 510K # K131321; UDI#(B)(4) WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT T7-S2 AI DUE TO KYPHOSIS. POST-OP, ROD BREAKAGE WAS DEVELOPED AT BOTH SIDE OF L5/S AND THE PATIENT WAS OBSERVED WITH RECURRENCE OF LOWER EXTREMITY NUMBNESS. REVISION SURGERY WAS PERFORMED IN WHICH 4-ROD FIXATION WAS CONSTRUCTED AFTER REMOVING THE TWO BROKEN RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565951 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention