BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5133848 · Received October 7, 2015

    Report

    Report Number
    1030489-2015-02583
    Event Type
    Injury
    Date Received
    October 7, 2015
    Report Date
    September 15, 2015
    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

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 828-083, 510K # K880215 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION; THEREFORE, CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT VCR AT LEVELS TH10-ILIAC TO TREAT KYPHOSIS. ON AN UNKNOWN DATE POST-OP, ROD BREAKAGE WAS FOUND. BONE FUSION HAS NOT BEEN ACHIEVED. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. L5/S ROD BROKE, SO FIXATION WAS DONE AT TH10/IL. REVISION SURGERY WAS DONE ON (B)(6) 2015. THE BROKEN ROD WAS REPLACED, AND THREE-ROD FIXATION WAS DONE. NO CHANGE IN LEVELS IMPLANTED. UNION WAS ACHIEVED. THE SURGEON THINKS THE EVENT MIGHT HAVE NOT OCCURRED IF HE HADN¿T PERFORMED PLIF AT LOWER VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662086 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention