BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY SUB-0 VISION CURETTE #6

    MDR report key: 2379116 · Received December 7, 2011

    Report

    Report Number
    1416605-2011-00004
    Event Type
    Other
    Date Received
    December 7, 2011
    Date of Event
    October 17, 2011
    Report Date
    December 5, 2011
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EKT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THICKNESS AT THE HEEL OF THE UNBROKEN WORKING END MEASURES 0.0185" AND THE THICKNESS IN THE MIDDLE OF THE BLADE MEASURES 0.0215". BOTH MEASUREMENTS ARE WITHIN THE SPECIFICATION OF 0.020" +/- 0.002." BASED ON VISUAL/DIMENSIONAL ANALYSIS, THE REASON FOR THE BREAKAGE OF THE INSTRUMENT CANNOT BE DETERMINED. ADD'L FUNCTIONAL TESTING WILL BE CONDUCTED.

    Description of Event or Problem · 1

    A PERIODONTIST WAS PERFORMING SCALING AND ROOT PLANNING ON PT'S SUPPER LEFT SIDE BETWEEN 12 & 13 WHEN THE CURETTE BROKE OFF AND BECAME EMBEDDED IN THE PT'S TISSUE. THE DOCTOR CONFIRMED WITH AN X-RAY THAT THE TIP WAS EMBEDDED AND THEN PROCEEDED TO PERFORM A PERIODONTAL FLAP SURGERY FOR REMOVAL THE TIP AND DEBRIDEMENT OF THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY SUB-0 VISION CURETTE #6 SGCSUB - 06 EKT HU-FRIEDY MFG. CO., LLC SGCSUB-06 0711

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other