BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02728

    MDR report key: 3120040 · Received May 20, 2013

    Report

    Report Number
    2520274-2013-02728
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, A PATIENT WAS TREATED FOR A MANDIBLE FRACTURE AND IMPLANTED WITH PLATE AND SCREWS. POST-OPERATIVELY ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH INFECTION. ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY TO HAVE THE SCREWS AND PLATE REMOVED. THE CONSTRUCT WAS REMOVED WITH NO REVISION IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222136 JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention