BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTROL CABLE W/CABLE SLEEVE

    MDR report key: 1002230 · Received February 20, 2008

    Report

    Report Number
    1818910-2008-00320
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDQ
    PMA / PMN Number
    K934557
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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

    DURING THE PROCEDURE THE CABLE DOESN'T GO THROUGH INTO THE SLEEVE CAUSING A SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTROL CABLE W/CABLE SLEEVE 87JDQ JDQ DEPUY ORTHOPAEDICS, INC. NA B4JHG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR