BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTION DRILL

    MDR report key: 1100807 · Received August 6, 2008

    Report

    Report Number
    1811755-2008-00037
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZA
    PMA / PMN Number
    K961970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAND PIECE WAS RECEIVED AND TESTED AT THE MANUFACTURING LOCATION, BUT THE BUR GUARD WAS NOT RETURNED TO THE MANUFACTURER. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE ALLEGED INCIDENT. THE CUSTOMER INDICATED THAT AN EXPIRED BUR GUARD WAS BEING USED FOR THIS WISDOM TOOTH REMOVAL. THE BURN WAS MOST LIKELY A RESULT OF THE BUR GUARD BEING WORN OUT AND USED PAST ITS EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WISDOM TOOTH REMOVAL, A PT RECEIVED A BURN ON THE INNER PORTION OF THE LIP. A TOPICAL OINTMENT WAS APPLIED TO THE BURN AT THE TIME THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION DRILL COMMAND II DZA STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention