BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA

    MDR report key: 2151741 · Received July 3, 2011

    Report

    Report Number
    2151741
    Event Type
    Malfunction
    Date Received
    July 3, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 3, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO BROKEN S1 FIRST SACRAL VERTEBRAE SCREWS EXPLANTED DUE TO SUSPECTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SOLERA SPINAL SYSTEM SCREW NKB MEDTRONIC SOFAMOR DANEK 2536644 H10D0138

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR