BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM CDH

    MDR report key: 1355132 · Received April 1, 2009

    Report

    Report Number
    1818910-2009-01462
    Event Type
    Injury
    Date Received
    April 1, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 5, 2009
    Manufacturer
    DEPUY INT'L, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K982918
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 PATIENT HAS A FRACTURED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-STEM CDH 87JDI; 87LZO; 87LZN JDI DEPUY INT'L, LTD. NA 1870150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention