BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3931923 · Received July 14, 2014

    Report

    Report Number
    1030489-2014-03237
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 3, 2014
    Report Date
    November 6, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K102555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE AT THE LEADING PORTION OF THE THREAD, THUS PREVENTING ENGAGEMENT INTO THE MAS HEAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE WITH HARDWARE INSTRUMENTATION. "THE SCREW WAS IMPLANTED AND THE SURGEON TRIED TO FIX THE ROD WITH THE SETSCREW. THAT DID NOT NOT WORK. THE SETSCREW DID NOT FIT INTO THE SCREW, AND THE SCREW WAS THEN EXPLANTED BECAUSE OF THIS. IT WAS ALSO REPORTED THAT THE SETSCREW WAS BROKEN AND NO FRAGMENTS WERE REMAINING IN THE PATIENT". NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409135 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H5089421

    Patients

    Seq Age Sex Outcome Treatment
    1