BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL PERFORMANCE SYSTEM SAW

    MDR report key: 205072 · Received January 4, 1999

    Report

    Report Number
    205072
    Event Type
    Injury
    Date Received
    January 4, 1999
    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 TOTAL PERFORMANCE SYSTEM SAW OSCILLATING SAW DZH STRYKER INSTRUMENTS 5100-31 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 * Required Intervention 2. FOOT PEDAL # 5100-8,| 3. BLADE.| 1. CONNECTED TO STRYKER CONSOLE # 5100,