BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SP2 IM ROD 400MM

    MDR report key: 1080174 · Received July 21, 2008

    Report

    Report Number
    1818910-2008-02955
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 21, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IM ROD WAS PINNED DOWN FOR FEMORAL CUT. AS SURGEON TOOK THE JIG OFF, THE IM ROD SNAPPED. 2-3 INCHES OF THE ROD REMAIN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SP2 IM ROD 400MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA