BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 5985901 · Received September 29, 2016

    Report

    Report Number
    1030489-2016-02690
    Event Type
    Injury
    Date Received
    September 29, 2016
    Report Date
    September 9, 2016
    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

    DATE OF IMPLANT IS UNKNOWN BUT IMPLANTATION SURGERY HAPPENED IN YEAR 2016. THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG #869-021 AND 510K# K040962 IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT "TES" SURGERY AT TH11(2 ABOVE 2 BELOW).POST-OP PATIENT HAD LOWER BACK PAIN DUE TO RODS AND SCREW BREAKAGE. DUE TO THIS A REVISION SURGERY WAS PERFORMED TO REPLACE THE RODS AND SCREWS. THE PATIENT HAD ALSO DEVELOPED INSTABILITY AND BONE UNION WAS NOT ACHIEVED. THE ROD WAS REPLACED WITH A COBALT CHROME ONE AND IT WAS REINFORCED USING 4 RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637911 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW,CROSSLINK