BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPUDENT-STA

    MDR report key: 1349718 · Received March 23, 2009

    Report

    Report Number
    3004082685-2009-00002
    Event Type
    Injury
    Date Received
    March 23, 2009
    Date of Event
    February 17, 2009
    Report Date
    March 23, 2009
    Manufacturer
    MILESTONE SCIENTIFIC
    Product Code
    EJI
    PMA / PMN Number
    K061904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAND PIECE WAS NOT RETURNED TO MILESTONE FOR EVALUATION. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ACTUAL FAILURE MODE. INFORMATION 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 HAND PIECE WITH A 30 GAGE 1 INCH LONG NEEDLE ATTACHED. THE PRODUCT LABELING (ATTACHED) RECOMMENDS A HAND PIECE WITH A 27 GAGE 1 1/4 INCH LONG NEEDLE ATTACHED FOR THIS TYPE OF AN INJECTION. WITHOUT THE ACTUAL HAND PIECE, 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A COMPUDENT-STA UNIT WAS USED IN CONJUNCTION WITH A WAND STA HANDPIECE TO PERFORM A DENTAL ANESTHETIC INJECTION. THE USER INSTALLED THE WAND STA HAND PIECE TO THE DRIVE UNIT AND PERFORMED A SUCCESSFUL LOWER BLOCK ANESTHETIC INJECTION. UPON REMOVING THE HAND PIECE FROM THE PATIENT'S MOUTH, THE NEEDLE SEPARATED FROM THE HAND PIECE, AND LODGED IN THE PATIENT'S BUCCALMUCOSA. THE PATIENT WAS TAKEN TO AN ORAL SURGEON, WHO WAS UNABLE TO LOCATE AND REMOVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPUDENT-STA EJI MILESTONE SCIENTIFIC STA5050-301 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other