BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04217

    MDR report key: 3222669 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04217
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN TFN. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED (B)(6) 2009 WITH A TROCHANTERIC FIXATION NAIL (TFN). PATIENT RETURNED TO SURGEON COMPLAINING OF MINOR HIP PAIN, AND WANTED NAIL REMOVED. EXAM INDICATED THAT THE FRACTURE WAS FULLY HEALED, AND THERE WAS NO BROKEN HARDWARE. PATIENT UNDERWENT TFN REMOVAL ON (B)(6) 2013. HARDWARE WAS REMOVED WITH NO PROBLEMS. PATIENT OUTCOME WAS REPORTEDLY GOOD. THIS REPORT IS FOR AN UNKNOWN TFN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321725 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention