BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL SCREW 3.5 X 30MM

    MDR report key: 1170002 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-04008
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KTW
    PMA / PMN Number
    K905048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 SCREW HEAD SNAPPED OFF DURING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL SCREW 3.5 X 30MM 87KTW KTW DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention