BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02476

    MDR report key: 3101857 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02476
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PMA/510K: CANNOT BE DETERMINED WITHOUT A PART NUMBER. 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

    THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN (B)(6) ON (B)(6) 2010 AND SUSTAINED A LEFT DISTAL FEMUR SHAFT FRACTURE THAT WAS TREATED WITH A SYNTHES DISTAL FEMUR LOCKING PLATE. THE PATIENT HAD REGULAR FOLLOW UP WITH THE SURGEON UNTIL (B)(6) 2011 AND X-RAY IMAGES SHOWED A NICELY HEALING DISTAL FEMUR FRACTURE WITH PLATE AND SCREWS IN GOOD POSITION AND NO SIGNS OF HARDWARE FAILURE. PATIENT REPORTEDLY PRESENTED ON (B)(6) 2011 WITH A BROKEN PLATE AND WAS RETURNED TO THE OR ON (B)(6) 2011 FOR REMOVAL OF THE BROKEN HARDWARE. THIS REPORT IS #1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203440 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention