BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT¿ SYSTEM

    MDR report key: 2770789 · Received October 3, 2012

    Report

    Report Number
    1030489-2012-01794
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAGE BROKE DURING INSERTION. FRAGMENTS SEEMED TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT¿ SYSTEM MQP MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA UK42

    Patients

    Seq Age Sex Outcome Treatment
    1