BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JET-X

    MDR report key: 610024 · Received June 2, 2005

    Report

    Report Number
    1020279-2005-00227
    Event Type
    Injury
    Date Received
    June 2, 2005
    Report Date
    June 2, 2005
    Manufacturer
    SMITH & NEPHEW, INC., OTHOPAEDIC DIVISION
    Product Code
    JHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REQUIRED WHEN THE DEVICE FRACTURE 3-4 WEEKS AFTER THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JET-X SHORT CENTRAL BODY JHW SMITH & NEPHEW, INC., OTHOPAEDIC DIVISION NA 04KM17500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R