BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON LEGACY SPINAL SYSTEM

    MDR report key: 1040445 · Received May 8, 2008

    Report

    Report Number
    1030489-2008-00228
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 14, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A LUMBAR SACRAL FUSION PROCEDURE. POST-OPERATIVE X-RAYS TAKEN IN 2008, REVEALED TWO SACRAL SCREWS BROKEN AT THE PROXIMAL PART. THE PT IS REPORTED TO BE EXPERIENCING SEVERE BACK PAIN AND INSTABILITY. THE PT UNDERWENT ADDITIONAL SURGERY TO REMOVE THE BROKEN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON LEGACY SPINAL SYSTEM SCREW KWP MEDTRONIC SOFAMOR DANEK USA NA H06E2300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention