BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1702025 · Received May 11, 2010

    Report

    Report Number
    1702025
    Event Type
    Malfunction
    Date Received
    May 11, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ORTHOPEDIATRICS CORP.
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING A SHORT LEG CAST, OUR KEEL BROKE ON A NEW SAW BLADE AS THEY MADE THE TURN AT THE PATIENT'S ANKLE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE KEEL ON THE SAW BLADE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SAW BLADE LGH ORTHOPEDIATRICS CORP. CA 2009 303136 *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR