BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUDENT/WAND PLUS

    MDR report key: 4890761 · Received July 1, 2015

    Report

    Report Number
    3004082685-2015-00001
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 30, 2015
    Manufacturer
    MILESTONE SCIENTIFIC
    Product Code
    EJI
    PMA / PMN Number
    K992819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS NOT RETURNED TO MILESTONE FOR EVAL. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ACTUAL FAILURE MODE. INFO FROM THE DENTIST'S INTERVIEW, A REVIEW OF THE PRODUCT LABELING AND FIELD RETURN DATA WAS USED IN THE ANALYSIS OF THIS EVENT. IN THIS CASE THE DENTIST USED A HANDPIECE WITH A 30 GAUGE 1 INCH LONG NEEDLE ATTACHED. THE PRODUCT LABELING RECOMMENDS A HANDPIECE WITH A 27 GAUGE 1 1/4 INCH LONG NEEDLE ATTACHED FOR THIS TYPE OF INJECTION. WITHOUT THE ACTUAL HANDPIECE, IT CANNOT BE DETERMINED IF THE USE OF THE SHORTER, THINNER NEEDLE CONTRIBUTED TO THIS ADVERSE EVENT. HOWEVER, THE USE OF A SHORTER NEEDLE WOULD MAKE RECOVERY OF THE NEEDLE MORE DIFFICULT. NOTE: THE NEEDLE IS NOT MANUFACTURED BY MILESTONE SCIENTIFIC. IT IS A PURCHASED ITEM.

    Description of Event or Problem · 1

    A COMPUDENT INSTRUMENT WAS USED IN CONJUNCTION WITH A WAND HANDPIECE TO PERFORM A DENTAL ANESTHETIC INJECTION. THE USER INSTALLED THE WAND HANDPIECE TO THE INSTRUMENT AND PERFORMED A SUCCESSFUL INFERIOR ALVEOLAR BLOCK INJECTION. AFTER DELIVERING THE FIRST CARTRIDGE, THE USER REMOVED THE NEEDLE FROM THE MANDIBULAR TISSUE, REPLACED THE SPENT CARTRIDGE WITH A NEW ONE, THEN GAVE THE SECOND INJECTION. UPON REMOVING THE HANDPIECE FROM PT'S MOUTH, THE NEEDLE SEPARATED FROM THE HANDPIECE AND LODGED IN THE PT'S BUCCALMUCOSA. THE PT WAS TAKEN TO AN ORAL SURGEON, WHO DISCUSSED TWO ALTERNATIVE TREATMENT PLANS WITH THE PT. THE SURGEON COULD SURGICALLY REMOVE THE NEEDLE OR LEAVE THE NEEDLE IN PLACE AND OBSERVE THE CONDITION, WITH THE OPTION OF REMOVAL AT A LATER TIME IF THE NEEDLE CREATED ANY PROBLEM. THE PT OPTED TO LEAVE THE NEEDLE IN PLACE FOR THE TIME BEING AND CONTINUE TO MONITOR THE SITUATION. THE PT WAS NOT EXPERIENCING ANY DISCOMFORT OR OTHER ISSUE DUE TO THE EMBEDDED NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426337 COMPUDENT/WAND PLUS EJI MILESTONE SCIENTIFIC WA-2050-301 140403

    Patients

    Seq Age Sex Outcome Treatment
    1 Other