BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2042786 · Received April 7, 2011

    Report

    Report Number
    1020279-2011-00117
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 6, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO THE PROXIMAL SCREWS BACKING OUT OF THE PLATE, CAUSING A MAL-REDUCTION. REVISION WAS SURGERY WAS PERFORMED APPROXIMATELY ONE WEEK POSTOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SMITH & NEPHEW ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R