BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3491043 · Received November 27, 2013

    Report

    Report Number
    1030489-2013-04825
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    October 31, 2013
    Report Date
    October 31, 2013
    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: THE FLANK OF THE FIRST MAS THREAD IS FRACTURED AND BENT DOWN, AND THE BOTTOM OF THE FIRST SET SCREW THREAD IS DAMAGED. THE ABOVE OBSERVATION IS CONSISTENT WITH MISALIGNMENT OF THE IMPLANTS DURING ATTEMPTED CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840017545, 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 L5-S1 TO TREAT ISTHMIC SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE PEDICLE SCREW AT S1 STRIPPED. THE SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619162 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG H13G1039

    Patients

    Seq Age Sex Outcome Treatment
    1