BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2010959 · Received February 23, 2011

    Report

    Report Number
    2010959
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPINAL FUSION PATIENT NOTED "SQUEAKING" IN BACK 8 WEEKS POST-OPERATIVELY. FOLLOW UP FILMS SHOWED FRACTURE OF THE PEDICLE SCREW AT ITS NECK.====================== MANUFACTURER RESPONSE FOR PEDICLE SCREW, CD HORIZON SPINAL SYSTEM======================DEVICE FAILURE WAS REPORTED TO THE VENDOR, WHO STATES IT WAS REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM PEDICLE SCREW, TITANIUM, MULTI AXIAL NKB MEDTRONIC SOFAMOR DANEK USA, INC. 75447555 *
    2 CD HORIZON SPINAL SYSTEM PEDICLE SCREW, TITANIUM, MULTI AXIAL NKB MEDTRONIC SOFAMOR DANEK USA, INC 75447550 *
    3 CD HORIZON SPINAL SYSTEM SET SCREW NKB MEDTRONIC SOFAMOR DANEK USA, INC 7540020 *
    4 CD HORIZON SPINAL SYSTEM ROD NKB MEDTRONIC SOFAMOR DANEK USA, INC 8690040 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R