BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6953993 · Received October 17, 2017

    Report

    Report Number
    1030489-2017-02216
    Event Type
    Injury
    Date Received
    October 17, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR QUANTITIES OF THE MENTIONED DEVICE WAS INVOLVED IN THE EVENT. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A SIMILAR DEVICE CATALOG # 75446545, 510K #K042025 AND UDI (B)(4) 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

    PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) LEVELS: L3/4 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, ADJACENT SEGMENTAL DISORDER WAS DEVELOPED AFTER SURGERY AT L3/4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734872 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other