BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4619512 · Received March 20, 2015

    Report

    Report Number
    1030489-2015-00589
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 20, 2015
    Report Date
    February 20, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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 POSTERIOR SPINAL FUSION TO TREAT A T12 FRACTURE. IT WAS REPORTED THAT DURING FINAL TIGHTENING, THE SET SCREW SHEARED OFF THE WALL OF THE HOOK. BOTH THE HOOK AND SET SCREW WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190058 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13B0800

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR