BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3740427 · Received April 10, 2014

    Report

    Report Number
    1030489-2014-02153
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440030, 510K # K102555 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: THE FLANK OF THE FIRST MAS THREAD IS DEFORMED UPWARD, CONSISTENT WITH MISALIGNMENT OF THE IMPLANTS DURING ATTEMPTED CONSTRUCT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SET SCREW WOULD NOT TIGHTEN DURING INSERTION INTO THE BONE SCREW. THE SCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216939 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H13J3877

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR BONE SCREW