BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02332

    MDR report key: 3092266 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02332
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDW
    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED ON UNKNOWN DATE WITH A TROCHANTERIC FIXATION NAIL (TFN) AND DISTAL TITANIUM LOCKING BOLT. SIX MONTHS POST-OPERATIVELY, THE PATIENT HAD NOT HEALED. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED A HYPERTROPHIC NON-UNION. THE DISTAL LOCKING BOLT WAS FOUND TO BE BROKEN. IT WAS NOTED BY THE SURGEON THAT THE SCREW WAS TAKING A FULL LOAD OVER SIX TO NINE MONTHS. THE SURGEON RETURNED THE PATIENT TO THE OPERATING ROOM ON (B)(6) 2013, TO REMOVE THE TFN AND THE LOCKING BOLT TO STIMULATE HEALING. THE PATIENT WAS REVISED TO A LATERAL FEMORAL NAIL. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN 4.9MM TITANIUM LOCKING BOLT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195367 JDW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention