BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL

    MDR report key: 1982732 · Received February 9, 2011

    Report

    Report Number
    1020279-2011-00031
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 27, 2010
    Report Date
    February 9, 2011
    Manufacturer
    SMITH-NEPHEW INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED DURING A HUMERAL NAIL PROCEDURE. THE DISTAL END OF THE NAIL PENETRATED THROUGH THE ANTERIOR CORTEX OF THE FEMUR DURING IMPLANTATION. THE NAIL WAS THEN REMOVED AND A PLATE WAS APPLIED. THE PATIENT'S BONE DENSITY WAS REPORTED TO BE SEVERLY OSTEOPENIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL JDS SMITH-NEPHEW INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R