BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3746260 · Received April 11, 2014

    Report

    Report Number
    1030489-2014-02171
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; ADDITIONALLY, ONE PORTION OF THREADS APPEAR TO HAVE MORE PRONOUNCE DAMAGE THAN THE REST, CONSISTENT WITH POSSIBLE THREAD JUMPING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT L2-L5 TO TREAT A L4 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE SET SCREW CRACKED DURING TIGHTENING. THE SET SCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221156 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H13J4151

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR