BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTS MICRO OSCILLATING SAW

    MDR report key: 204435 · Received December 29, 1998

    Report

    Report Number
    204435
    Event Type
    Injury
    Date Received
    December 29, 1998
    Date of Event
    November 11, 1998
    Report Date
    November 16, 1998
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STRYKER SAW WAS USED ON OPERATION IN THE MOUTH. AFTER OPERATION, WHEN SAW WAS REMOVED, 3-4 CUTS WERE NOTED AT THE RIGHT COMMISSURE OF THE MOUTH. THEY WERE 5-6 MM IN LENGTH. THE LACERATIONS REQUIRED SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTS MICRO OSCILLATING SAW SAW, AC, POWERED DZH STRYKER INSTRUMENTS 5100-031-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention CONNECTED TO STRYKER CONSOLE 5100-001-000| FOOT PEDAL 5100-008-000| BLADE 2296-031-3251