BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL AND LARGE PLATE SET

    MDR report key: 3840815 · Received May 23, 2014

    Report

    Report Number
    MW5036357
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON E-MAILED PICTURE OF A DISTAL RADIUS (VOLAR) PLATE THAT HAD FRACTURED, WHICH REQUIRED INTERVENTION TO REMOVE THE BROKEN PLATE. SURGEON NOTED IN SECOND E-MAIL THAT THE PT WAS A SMOKER, HE PERFORMED A CORRECTIVE OSTEOTOMY AND HE USED THE PLATE TO DISTRACT THE DISTAL RADIUS MAL-UNION. HE ALSO NOTED THAT THE PT WAS A HIGH RISK FOR THIS EVENT TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307095 SMALL AND LARGE PLATE SET METALLIC BONE FIXATION PLATE HRS FLOWER ORTHOPEDICS FDR 506 2013003467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention