BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS/DCS IMPLANT

    MDR report key: 2914416 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00332
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    SYNTHES (B)(6) REPORTED AN EVENT AS FOLLOWS: PATIENT WAS IMPLANTED WITH A DYNAMIC CONDYLAR SCREW PLATE CONSTRUCT ON AN UNKNOWN DATE. PATIENT EXPERIENCED AN INFECTION AND NON-UNION OF THE FEMUR. SURGEON STATED THAT WHILE OPENING THE PATIENT, PUS AND FLUID STREAMED FROM THE INCISION. THE SURGEON STOPPED THE PROCEDURE AND DECIDED TO TREAT THE PATIENT NON-OPERATIVELY. NO REMOVAL OR REVISION HAS TAKEN PLACE AT THIS TIME. THE DCS IMPLANTS REMAIN IN THE PATIENT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20707 DHS/DCS IMPLANT HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW