BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM OSTEOPENIA SCREWS

    MDR report key: 2882438 · Received December 20, 2012

    Report

    Report Number
    1020279-2012-00698
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO SCREW BREAKING AT SCREW/BONE INTERFACE BELOW PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM OSTEOPENIA SCREWS SCREW HWC SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R