BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 5093702 · Received September 22, 2015

    Report

    Report Number
    1030489-2015-02460
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 1, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH 510K NUMBER K040962 WITH CATALOG NUMBER: 869-021 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    LEVELS IMPLANTED: TH4-ILIAC IT WAS REPORTED THAT A PATIENT UNDERWENT VCR (VERTEBRAL COLUMN RESECTION) IN (B)(6) 2014. VERY RECENTLY A ROD WAS CONFIRMED TO BE BROKEN AND REVISION SURGERY WILL BE PERFORMED IN (B)(6) 2015. VCR WAS CONDUCTED AT THE LEVELS WHERE THE ROD GOT BROKEN (DETAIL IS UNKNOWN).REVISION SURGERY WAS PLANNED IN (B)(6) 2015. NO COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626689 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention