BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2991341 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00692
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 5, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE AT L3-5 SKIPPING L4 DUE TO FRACTURE OF THE L4 VERTEBRAE. A PPROXIMATELY 3-4 YEARS POST-OP THE PATIENT BEGAN FEELING PAIN. AFTER AN MRI IT WAS NOTICED THAT THE SET SCREW WAS DISLODGED. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE HARDWARE. IT WAS FOUND THAT THE BONE SCREW WAS BROKEN. THE SHAFT COULD NOT BE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96202 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA W04J1446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention