BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE BENDING CLAMP

    MDR report key: 2243990 · Received September 7, 2011

    Report

    Report Number
    MW5022164
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE EQUIPMENT WAS IN USE, FOR THE ORIF OF LEFT CLAVICLE, A SMALL PROMINENCE BROKE OFF THE CLAMP-ABOUT 1/4" IN SIZE. X-RAY COMPLETED NOT FINDING A FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE BENDING CLAMP HRS SYNTHES ITEM # 03.211.005

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention