BEUDAMED
    FDA Adverse Event Summary report: N

    NI

    MDR report key: 1982434 · Received January 31, 2011

    Report

    Report Number
    2520274-2011-00007
    Date Received
    January 31, 2011
    Report Date
    January 5, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. CANNOT BE DETERMINED WITHOUT A CATALOG NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON ADVISED A PT WAS IMPLANTED WITH 4 STERNAL PLATES ON AN UNK DATE. TWO OF THE FOUR PLATES WERE NOTED AS BROKEN. PT WAS RETURNED TO THE OPERATING ROOM FOR REVISION. ALL PLATES WERE REMOVED AND PT WAS RE-PLATED WITH ALL NEW HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI STERNAL PLATES HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS