BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3746254 · Received April 11, 2014

    Report

    Report Number
    1030489-2014-02172
    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: THE HEX HEAD OF THE SCREW IS CRACKED. THE CRACK HAS STARTED IN THE CORNER OF THE HEX, AS IS CONSISTENT WITH BEND STRESS OVERLOAD. THE THREADS OF THE SCREW ARE NOT DAMAGE BUT THERE ARE WITNESS MARKS ON THE BOTTOM THAT INDICATE USE. THIS APPEARS TO BE THE RESULT OF BEND STRESS OVERLOAD.

    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
    221151 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H13J4148

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR