BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAGE

    MDR report key: 2895790 · Received January 3, 2013

    Report

    Report Number
    2520274-2013-00058
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    LYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH CAGE ON AN UNKNOWN DATE. AFTER 3 MONTHS (POST OP CONTROL) THE CAGE IS SINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2779 CAGE LYT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention