BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORE INTRA-ORAL BLADE

    MDR report key: 1080919 · Received July 22, 2008

    Report

    Report Number
    9616696-2008-00031
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    Product Code
    GFA
    PMA / PMN Number
    K040300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. WORK ORDER DOCUMENTATION REVIEWED, AND ALL SPECIFICATIONS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE OFF FROM THE SHAFT DURING MANDIBULAR SURGERY. AN ADD'L INCISION WAS MADE IN ORDER TO REMOVE THE BROKEN BLADE FROM THE PT. THERE WERE NO FURTHER CONSEQUENCES TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE SAW BLADES AND ACCESSORIES GFA STRYKER IRELAND LTD., INSTRUMENTS DIVISION 08071017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK