BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT INSTRUMENTS

    MDR report key: 1840157 · Received September 21, 2010

    Report

    Report Number
    2242816-2010-00127
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PART OF THE DRILL BIT BROKE OFF ABOUT 1CM DEEP INTO THE S1 BODY.PATIENT OUTCOME: PATIENT RETAINED THE EMBEDDED PART OF THE DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT INSTRUMENTS RIGID DRILL- LONG HTW EBI, LLC 016052

    Patients

    Seq Age Sex Outcome Treatment
    1