BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2922879 · Received January 18, 2013

    Report

    Report Number
    2520274-2013-00476
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS 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

    REPORTEDLY, THE PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2009 AND THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2011 FOR REMOVAL OF HARDWARE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT WAS IMPLANTED WITH A PLATE (B)(6) 2009. THE PLATE WAS NOTED AS BROKEN AFTER 13 MONTHS. THE PATIENT WAS RETURNED TO THE OR FOR REMOVAL AND REVISION TO ANOTHER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27460 PLATE PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS