BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3692402 · Received March 21, 2014

    Report

    Report Number
    1030489-2014-01911
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    April 1, 2013
    Report Date
    February 20, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 869-021, 510K # K040962 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 FUSION AT T10-ILIAC TO TREAT DEGENERATIVE SCOLIOSIS. APPROXIMATELY ELEVEN MONTHS POST-OP THE RODS BROKE AT L4/5. THE PATIENT DID NOT REPORT PAIN BUT DID NOTICE A METAL BUMPING NOISE WHEN MOVING. A REVISION SURGERY MAY BE PERFORMED BUT HAS NOT TAKEN PLACE AT THIS TIME. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170307 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0190503W

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR VB REPLACEMENT, SCREW, SET SCREW