BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 5716335 · Received June 10, 2016

    Report

    Report Number
    1030489-2016-01750
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    May 16, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MNH
    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 # 8110611, 510K # K010249 WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POSTOPERATIVE INFECTION IN WHICH DEBRIDEMENT AND EXTENSION OF FUSION TILL TH11 WAS DONE.POST-OP DOMINO WHICH WAS IMPLANTED FOR CONNECTING LEFT RODS BACKED OUT.REVISION IS SCHEDULED FOR REIMPLANTATION OF BACKED-OUT DOMINO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372922 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION MNH WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention