BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS GLIDING NAIL

    MDR report key: 1923505 · Received December 14, 2010

    Report

    Report Number
    8010764-2010-00017
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 15, 2010
    Report Date
    May 5, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRUCTURE OF THE FRACTURE SURFACE INDICATES A FRACTURE RUNNING FROM THE LATERAL SIDE IN MEDIAL DIRECTION. THE ASSUMED FRACTURE ORIGIN CAN NOT BE CONFIRMED DUE TO SECONDARY DAMAGE. NO MATERIAL DEFECTS OR ABNORMALITIES COULD BE DETECTED. THE ENTIRE FRACTURE SURFACE SHOWS STRIATIONS INDICATIVE OF BREAKAGE DUE TO MATERIAL FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL FRACTURED AFTER IMPLANTATION REQUIRING A REVISION SURGERY TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS GLIDING NAIL NAIL JDS SMITH & NEPHEW, INC. D0810720

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention (B)(4)| (B)(4)