BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3763343 · Received April 22, 2014

    Report

    Report Number
    1030489-2014-02253
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL ANALYSIS REVEALS THAT ALL COMPONENTS OF THE SCREW ARE STILL THERE. THE DAMAGE IS TO THE FEMALE TORX AT THE DISTAL END OF THE BONE SCREW. THE OUTER PORTION OF THE TORX IS STRIPPED FROM WHAT APPEARS TO BE THE DRIVER NOT BEING FULLY SEATED AND THEN TORSIONALLY OVERLOADED. THE DAMAGE AND STRIPPING OF THE SCREW HEAD IS CONSISTED WITH TORSIONAL OVERLOAD AIDED BY THE DRIVER NOT BEING FULLY SEATED.

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840016550, 510K # K091974 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L3-4. IT WAS REPORTED THAT THE SCREW AT L4 STRIPPED DURING INSERTION. THE SCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241888 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H13K0918

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWDRIVER