BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1060428 · Received June 9, 2008

    Report

    Report Number
    1060428
    Event Type
    Injury
    Date Received
    June 9, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 6, 2008
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS RETURNED TO THE O.R. FOR AN OPEN REDUCTION. INTERNAL FIXATION OF THE RIGHT ULNA FOR REMOVAL OF A BROKEN RECONSTRUCTION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * 7 HOLE RECONSTRUCTION PLATE HRS SYNTHES * *
    2 * 7 HOLE RECONSTRUCTION PLATE HRS SYNTHES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention