BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3755655 · Received April 17, 2014

    Report

    Report Number
    1030489-2014-02207
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 SURGICAL PROCEDURE AT T11-L2 TO TREAT MULTIPLE SPINAL FRACTURES. IT WAS REPORTED THAT DURING FINAL TIGHTENING OF THE T11 SET SCREW, THE SET SCREW WOULD NOT BREAK OFF AS IT SHOULD. THE AREA AT T11 WAS OPENED UP A BIT MORE AND IT WAS NOTICED THAT THERE WAS METAL POWDER AT THE SITE. THE SET SCREW WAS REMOVED AND REPLACED WITH A NEW SET SCREW. FINAL TIGHTENING AND BREAK OFF WERE SUCCESSFUL. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235193 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H13T2004

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other BONE SCREW