BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6306339 · Received February 7, 2017

    Report

    Report Number
    1030489-2017-00255
    Event Type
    Injury
    Date Received
    February 7, 2017
    Report Date
    January 13, 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 #1475006150, 510K # K121680 WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2015, PATIENT UNDERWENT POSTERIOR FUSION. ON AN UNKNOWN DATE, POST-OP, RODS BROKE. ACCORDING TO THE SURGEON, BONE UNION HAD BEEN ACHIEVED. RODS OF BOTH THE SIDE BROKE AFTER THE ACHIEVEMENT OF BONE UNION. FUSED RANGE WAS T12-L4. LEVELS ON WHICH ROD BREAKAGE OCCURRED WERE UNKNOWN. THE IMPLANTS ARE PLANNED TO BE REMOVED ON TUESDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91670 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention