BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM SOLID TIBIAL NAIL

    MDR report key: 179511 · Received July 24, 1998

    Report

    Report Number
    2520274-1998-00052
    Event Type
    Malfunction
    Date Received
    July 24, 1998
    Date of Event
    June 25, 1997
    Report Date
    July 21, 1998
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED COMMINUTED TIBIA AND FIBULA FRACTURES. ON 8/25/1995, A TITANIUM SOLID TIBIAL NAIL WAS IMPLANTED INTO THE PT. ON 6/25/1997, IT WAS NOTED BY X-RAY THAT THE NAIL HAD FRACTURED. REMOVAL OF THE FRACTURED NAIL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM SOLID TIBIAL NAIL Implant SOLID NAILS HSB SYNTHES USA NA A3AD105

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other