BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL/TRI LOCK ANT INSERTER SHAFT

    MDR report key: 1924430 · Received December 7, 2010

    Report

    Report Number
    1818910-2010-09819
    Event Type
    Injury
    Date Received
    December 7, 2010
    Report Date
    October 29, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    THE TIP OF THE INSTRUMENT BROKE OFF DURING SURGERY (LEFT IN PROSTHESIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL/TRI LOCK ANT INSERTER SHAFT 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA PG0909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention