BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6709786 · Received July 13, 2017

    Report

    Report Number
    1030489-2017-01750
    Event Type
    Injury
    Date Received
    July 13, 2017
    Report Date
    June 16, 2017
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 70467570, 510K # K050439 AND (B)(4) WAS CLEARED IN THE UNITED STATES. (B)(4). PRODUCT WAS NOT 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

    LEVELS INVOLVED: T10-S2AI IT WAS REPORTED THAT ON UNKNOWN DATE , POST OP, SCREWS WERE FOUND LOOSE. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490663 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0253823W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention