BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1010165 · Received March 6, 2008

    Report

    Report Number
    1030489-2008-00124
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Report Date
    February 15, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MEDTRONIC FOR EVALUATION. EXAMINATION OF X-RAYS TAKEN IN 2008, REVEAL A RIGHT SIDE S1 SCREW IS FRACTURED AND DISPLACEMENT SEVERAL MM. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT X-RAY IMAGES TAKEN IN 2008, REVEAL A BROKEN SCREW AT S1. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SCREW KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1