BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL

    MDR report key: 4152441 · Received July 3, 2014

    Report

    Report Number
    2032480-2014-00006
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED ORTHOPAEDIC SOLUTIONS WAS NOTIFIED OF THIS EVENT. THE DEVICE WAS NOT RETURNED, WE HAVE MADE NUMEROUS ATTEMPTS TO FOLLOW UP AND GATHER INFO TO AID IN OUR INVESTIGATION WITH NO SUCCESS. THE ONLY INFO GIVEN AT THE TIME OF THE NOTIFICATION WAS THE PT NAME, DOCTOR (B)(6) WITH AN EXPLANATION THE INITIAL PROCEDURE WAS PERFORMED IN EITHER (B)(6). WE CHECKED OUT RECORDS AND COULD NOT CONFIRM THE PTS CAME FOR THESE LOCATIONS. THIS IS WHY WE COULD NOT REPORT MORE DETAILED INFO SUCH AS THE DEVICE PART NUMBER, OR LOT NUMBER. IF WE RECEIVE ANY ADDITIONAL INFO WE WILL FORWARD THIS TO YOU. AGAIN THERE HAS BEEN NO RESPONSE TO OUR ATTEMPTS TO COLLECT INFO.

    Description of Event or Problem · 1

    WE RECEIVED NOTICE OF A NAIL FAILURE. WE HAVE ATTEMPTED TO GATHER MORE INFO, OR HAVE THE DEVICE RETURNED WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391546 TROCHANTERIC NAIL INTRA MEDULLARY FIXATION HSB ADVANCED ORTHOPAEDIC SOLUTIONS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention