BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBCLOVERLEAF FOOTPL1.3 TYPE C F/CMF

    MDR report key: 2211276 · Received August 4, 2011

    Report

    Report Number
    2939274-2011-00503
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 7, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A RECEIVED DEVICE REPORT FROM SYNTHES (B)(4) INDICATED: THE FOOTPLATE BROKE INTO TWO PIECES AFTER COMPLETION OF CONSOLIDATION PERIOD OF DISTRACTION. FOOTPLATE REVISED. REPORTEDLY, IT DID NOT AFFECT THE BONE OSTEOGENESIS. REVISION REQUIRED TO REPAIR FOOTPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANDIBCLOVERLEAF FOOTPL1.3 TYPE C F/CMF : MANDIBLE CLOVERLEAF FOOT MQN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1