BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND BURR

    MDR report key: 12904 · Received April 22, 1994

    Report

    Report Number
    MW1001693
    Event Type
    Malfunction
    Date Received
    April 22, 1994
    Date of Event
    April 5, 1994
    Report Date
    April 13, 1994
    Manufacturer
    MICRO-AIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOUR MM DIAMOND BURR SHATTERED DURING USED IN SURGICAL SITE. PROCEDURE WAS LAMINECTOMY AND DISCECTOMY L1 AND L2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND BURR DIAMOND BURR HTT MICRO-AIRE SURGICAL INSTRUMENTS, INC. NA 0294B0156

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other