BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3905106 · Received July 1, 2014

    Report

    Report Number
    1030489-2014-02983
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L2-4. IT WAS REPORTED THAT TWO YEARS POST-OP, THE PATIENT UNDERWENT A REMOVAL SURGERY. IT WAS REPORTED THAT THE CROSSLINK MIDLINE NUT STRIPPED DURING REMOVAL AND WAS UNABLE TO BE LOOSENED. THE CROSSLINK WAS CUT AND REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384065 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0205274W

    Patients

    Seq Age Sex Outcome Treatment
    1 RODS