BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE / DZK

    MDR report key: 1379344 · Received May 11, 2009

    Report

    Report Number
    1020279-2009-00562
    Event Type
    Injury
    Date Received
    May 11, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 8, 2009
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    DZK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE K-WIRE BENT APPROXIMATELY 6 WEEKS AFTER THE INITIAL SURGERY, AND THAT A REVISION SURGERY WAS REQUIRED TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE / DZK DZK BROOKS MANUFACTURING SITE 08DM10187

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R