BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02719

    MDR report key: 3120038 · Received May 20, 2013

    Report

    Report Number
    2520274-2013-02719
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A RECON FEMORAL NAIL VIA LATERAL ENTRY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT COMPLAINT OF PAIN. THE SURGEON REMOVED TWO LOCKING SCREWS, ONE RECON SCREW AND ONE CABLE. THE RECON FEMUR NAIL WAS LEFT IN THE PATIENT. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221445 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention