BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR, OVAL, 4MM X 69MM, STERILE

    MDR report key: 1182311 · Received September 17, 2008

    Report

    Report Number
    1182311
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    OSTEOMED
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    OSTEOMED DRILL LOADED WITH OSTEOMED BURR REF # 450-6140-SP; OVAL BURR TIP SNAPPED OFF SHAFT WHEN BURR MADE CONTACT WITH BONE.====================== MANUFACTURER RESPONSE FOR BURR, OVAL, 4MM X69MM, STERILE, OSTEOMED======================FIELD REP NOTIFED. HE WILL COLLECT THE BURR THIS WEEK FOR COMPANY INVESTIGATION. HE STATES, "THERE IS A SHORTER BURR WHICH MAY HAVE BEEN A BETTER SELECTION FOR THE PROCEDURE". HE WILL EDUCATE THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURR, OVAL, 4MM X 69MM, STERILE DRILL TIP HTT OSTEOMED 450-6140-SP *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR