BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2896665 · Received January 4, 2013

    Report

    Report Number
    1030489-2013-00016
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    July 23, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A DUPLICATE OF EVENT FROM REPORT 1030489-2012-01870. GOING FORWARD ALL NEW INFORMATION WILL BE SUBMITTED AS A SUPPLIMENTAL OF 1030489-2012-01870.

    Additional Manufacturer Narrative · 1

    FILMS WERE SUPPLIED FOR REVIEW. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. FOUR MONTHS POST-OP IT WAS REPORTED THAT THE RODS BROKE. THE PATIENT UNDERWENT A REVISION SURGERY 7 MONTHS POST-OP TO REMOVE THE HARDWARE. THE PATIENT REPORTED EXPERIENCING PAIN AFTER A SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN OPEN LAMINECTOMY AT L4, L3, L2; DECOMPRESSION OF THE THECAL SAC L2-3-4-5 NERVE ROOTS; CORRECTION OF SCOLIOSIS AND REDUCTION OF L4-5 SPONDYLOLISTHESIS. THE PATIENT FELT AN INCREASE IN BACK PAIN WHILE DOING HAMSTRING STRETCHES 5 MONTHS POST-OP. THE PAIN HAS FURTHER PROGRESSED INTO BOTH LEGS. IT WAS FOUND THAT THE HARDWARE WAS FRACTURED AT THE L4-5 LEVEL AND AS A RESULT THE SPONDYLOLISTHESIS HAS RETURNED TO PREOPERATIVE LEVELS. THE PATIENT UNDERWENT A REVISION SURGERY FOR REMOVAL OF BILATERAL L2, 3, 4, 5 PEDICLE SCREWS, BROKEN RODS, ILIAC CONNECTORS. THE OLD HARDWARE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4197 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention