BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1132243 · Received July 31, 2008

    Report

    Report Number
    1030489-2008-00413
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    February 27, 2008
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE REPORTED TO BE UNAVAILABLE TO RETURN FOR EVAL. NO X-RAYS WERE PROVIDED FOR REVIEW. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SCREW KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *