BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0 INTERNAL CAPTURE

    MDR report key: 2130439 · Received June 16, 2011

    Report

    Report Number
    1020279-2011-00200
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE WAS CORRECTED TO 12/01/2009.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - ADDED.WAS THE DEVICE EVALUATED BY THE MANUFACTURER? ANSWERED YES.

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED TO REMOVE AND REPLACE A BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0 INTERNAL CAPTURE NT HEX CAP SCR 5.0MM X 75MM HWC SMITH & NEPHEW, INC. 71642275 09MM06193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) LOT# 09LT36795