BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5821708 · Received July 26, 2016

    Report

    Report Number
    1030489-2016-02179
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 30, 2016
    Report Date
    June 30, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    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 # 8115530, 510K # K030840 WAS CLEARED IN THE UNITED STATES. 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 THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY FOR COMPRESSION FRACTURE. POST-OP, REVISION SURGERY WAS PERFORMED DUE TO UNSUCCESSFUL BONE UNION. DURING REVISION SURGERY, WHEN THE SURGEON TRIED TO REMOVE A PLACED CROSSLINK AT TH10/11, A RIGHT GOLDEN SCREW WAS STRIPPED AND IT COULD NOT BE REMOVED. THE CROSSLINK PLACED AT TH10/11 WAS REMAINED IN THE PATIENT. THERE WAS OVERALL DELAY IN PROCEDURE LESS THAN 60 MIN. REPORTEDLY, THE PATIENT IS GOING WELL AFTER THE SURGERY (BACK PAIN WAS RESOLVED) AND DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475563 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0062400W

    Patients

    Seq Age Sex Outcome Treatment
    1