BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAPERED C-1

    MDR report key: 495753 · Received November 12, 2003

    Report

    Report Number
    1625507-2003-00154
    Event Type
    Other
    Date Received
    November 12, 2003
    Date of Event
    August 1, 2000
    Report Date
    October 7, 2003
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DRILL BIT BROKE IN TWO EQUAL PIECES. LEFT ANTERIOR/LATERAL ORBITOTOMY WITH REMOVAL OF BONE FOR DECOMPRESSION. WHILE USING THE MIDAS REX DRILL BIT TO REMOVE THE LATERAL ORBITAL WALL, THE BIT BROKE IN TWO EQUAL PIECES. BOTH PIECES WERE RECOVERED FROM THE OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED C-1 SURGICAL DISSECTING TOOL HBE MEDTRONIC MIDAS REX NA P5221

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention