BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREWS, REGULAR

    MDR report key: 2842958 · Received November 21, 2012

    Report

    Report Number
    8010764-2012-00048
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED BECAUSE THE LAG CREW BROKE 8 MONTHS POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREWS, REGULAR CHS GLEITSCH.RÜCKW.SCHN.85MM HWC SMITH & NEPHEW, INC. 11ET06821

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R (B)(4)