BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1900519 · Received October 28, 2010

    Report

    Report Number
    1030489-2010-01389
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MFG
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT T8-S1 THREE YRS AGO. NO INTERBODY FUSION WAS PERFORMED AT L4-L5. THE ROD REPORTEDLY BROKE AT LEFT SIDE L4-L5. NO REVISION SURGERY IS REPORTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR IMPLANTED:| SET SCREW:| IMPLANTED:| PEDICLE SCREW: