BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE INTRA-ORAL BLADE;OSCILLATING 7MM SAW BLADE

    MDR report key: 1427149 · Received July 11, 2009

    Report

    Report Number
    1427149
    Event Type
    Malfunction
    Date Received
    July 11, 2009
    Date of Event
    June 2, 2009
    Report Date
    July 11, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE CASE AT TWO DIFFERENT TIMES WE HAD TO REPLACE OSCILLATING INTA-ORAL 7MM SAW BLADE BECAUSE IT BROKE WHILE THE SURGEONS WERE USING IT IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE;OSCILLATING 7MM SAW BLADE INTRA-ORAL BLADE, OSCILLATING DZH STRYKER INSTRUMENTS NA 31309010825501780-08255017

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR