BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY MFG. CO., LLC

    MDR report key: 5651818 · Received May 12, 2016

    Report

    Report Number
    1416605-2016-00003
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 29, 2016
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    DZN
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DENTAL PROCEDURE, THE INSTRUMENT WAS USED TO CHECK FOR MOBILITY OF TOOTH. THIS INSTRUMENT'S INTENDED USE IS FOR REFLECTING AND RETRACTING THE MUCOPERIOSTEUM AFTER INCISIONS OF THE GINGIVAL TISSUE. NO MANUFACTURING DEFECTS WERE FOUND DURING EVALUATION. THERE IS A LOW LEVEL OF RETURN RATES ON THIS INSTRUMENT. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT NUMBER WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED. THE DEVICE IS NOT EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE ADVERSE EVENT OCCURRED WHILE THE PATIENT WAS HAVING EXTENSIVE DENTAL WORK. THE DENTIST WAS USING THE INSTRUMENT INTERPROXIMALLY BETWEEN TOOTH 3 AND 4 TO CHECK FOR MOBILITY WHEN THE DEVICE FRACTURED. THE DENTIST CALLED THE ENT INTO THE OPERATING ROOM, WHERE AN X-RAY OF SKULL AND CT OF HEAD WERE ORDERED. THE RESULTS CONFIRMED A 1-2CM PIECE WAS LODGED IN THE RIGHT POSTERIOR MAXILLARY SINUS. THE ENT REMOVED THE FOREIGN BODY. GENERAL ANESTHESIA WAS ADMINISTERED DURING THE REMOVAL OF THE FOREIGN BODY. THE PATIENT WAS KEPT OVERNIGHT AND DISCHARGED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306644 HU-FRIEDY MFG. CO., LLC PERIOSTEAL DZN HU-FRIEDY MFG. CO., LLC PFIWDS1 1014

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization