BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3694804 · Received March 24, 2014

    Report

    Report Number
    1030489-2014-01914
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 23, 2014
    Report Date
    February 23, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    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 # 5442141, 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 TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-S1. IT WAS REPORTED THAT THE CROSSLINK SET SCREW STRIPPED DURING FINAL TIGHTENING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173291 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0285539W

    Patients

    Seq Age Sex Outcome Treatment
    1 RODS, SCREWS