BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01589

    MDR report key: 3010132 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01589
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    October 14, 2010
    Manufacturer
    SYNTHES (USA) WEST CHESTER, PA
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. X-RAY TAKEN - EXACT DATES ARE UNKNOWN. EXACT PART NUMBER COULD NOT BE IDENTIFIED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT AND NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    AN EDUCATIONAL PRESENTATION REPORTED PRE AND POST ROD BREAKAGE, INFECTION AND PAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114569 MCV SYNTHES (USA) WEST CHESTER, PA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention