BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOS TROCHANTERIC NAIL

    MDR report key: 1880280 · Received October 20, 2010

    Report

    Report Number
    2032480-2010-00007
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K021008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN 11MM AOS SHORT TROCHANTERIC NAIL. ACCORDING TO THE SURGEON, THE PT DEVELOPED A NONUNION. THE REPORT REACHED THE SALES REP ON 09/21/2010 THAT THE NAIL HAD BROKEN AND THAT THE NAIL NEEDED TO BE EXTRACTED. THE SALES REP WAS NOT PRESENT AT THE SURGERY BUT LATER FOUND OUT THAT THE NAIL BROKE AT THE LAG SCREW HOLE. ACCORDING TO THE SURGEON, THE PT REMAINED ACTIVE IN SPITE OF THE NONUNION. THE SURGEON HAS ASKED FOR THE NAIL TO BE SENT BACK AFTER PATHOLOGY HAS LOOKED AT IT. AT THE TIME OF THIS FILING, THE NAIL HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AOS TROCHANTERIC NAIL INTERMEDULLARY ROD HSB ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 1036-200 09012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention