BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 5852878 · Received August 8, 2016

    Report

    Report Number
    1030489-2016-02293
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 12, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG # 76446550 AND 510K# K042025 IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY DUE TO STENOSIS. POST-OP, THE SCREWS LOOSENED. THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE PRODUCTS WERE REPLACED (L5/S). NO PATIENT COMPLICATIONS WERE REPORTED POST THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505008 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H10F2427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention