BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUFLEX MCP IMPLANT SZ 30

    MDR report key: 1349995 · Received March 19, 2009

    Report

    Report Number
    1818910-2009-01179
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    February 20, 2009
    Report Date
    February 20, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    K970544
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE IMPLANT FINGER WAS BROKEN AT BASE OF THE DISTAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUFLEX MCP IMPLANT SZ 30 87KYJ KYJ DEPUY ORTHOPAEDICS, INC. NA CN8KH1000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention