BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INC

    MDR report key: 8495603 · Received April 9, 2019

    Report

    Report Number
    3003444492-2019-00001
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 5, 2019
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EIGHT (8) SAMPLES FROM THE REPORTED LOT NO WERE RETURNED TO PRIMA DENTAL GROUP FOR EVALUATION. VISUAL INSPECTION CARRIED OUT BY THE QA DEPT CONFIRMED ALL 8 TO BE IN A GOOD CONDITION WITH NO OBVIOUS SIGNS OF DAMAGE AND/OR DETERIORATION. USING A CALIBRATED 0-25MM EXTERNAL DIGITAL MIRCOMETER (ASSET NO DM002, LAST CALIBRATED 02/01/2019, CALIBRATION DUE DATE 05/01/2019), EACH OF THE 8 BURS WERE MEASURED IN 2 PLACES ACROSS THE OD OF THE SHANK. THE RESULTS OBTAINED ARE AS SHOWN BELOW. SHANK OD SPECIFICATION - 1.590 TO 1.600MM: SAMPLE #1 - 1.595/1.596, SAMPLE #2 - 1.595/1.596, SAMPLE #3 - 1.595/1.596, SAMPLE #4 - 1.595/1.596, SAMPLE #5 - 1.595/1.596, SAMPLE #6 - 1.595/1.596, SAMPLE #7 - 1.595/1.596, SAMPLE #8 - 1.595/1.596. AS A SECONDARY TEST THE BURS WERE CHECKED FOR FIT AND PERFORMANCE USING A SS WHITE HAND PIECE (E0151). IN EACH CASE THE BURS LOCKED SECURELY INTO THE HAND PIECE AND WHEN TESTED ON MACOR, A MACHINEABLE GLASS CERAMIC, PERFORMED AS PER INTENDED BY THE MANUFACTURER. IN ORDER TO ASCERTAIN MORE DETAILS ABOUT THE PROCEDURE BEING CONDUCTED AT THE TIME OF THE REPORTED INCIDENTS AND THE CONDITION OF THE HAND PIECE ITSELF, A PRODUCT DEVIATION REPORT (FRM-12.A0) WAS SENT TO THE IMPORTER FOR FORWARDING TO THE USER. UNFORTUNATELY NO DETAILS REGARDING THE TYPE AND CONDITION OF THE HAND PIECE (REF SERVICE HISTORY) WERE PROVIDED. FROM THE FINDINGS OF OUR INVESTIGATION WE COULD FIND NO FAULT WITH ANY OF THE BURS RETURNED IN SUPPORT OF THE COMPLAINT. THE DHR FOR THE LOT NO INDICATED NO PROBLEMS WERE EXPERIENCED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    WHILE DELIVERING A CROWN ON A (B)(6) MALE PATIENT, THE ENTIRE BUR FELL OUT OF THE HAND PIECE INTO THE PATIENTS MOUTH. THE PATIENT SWALLOWED THE BUR AND WAS SENT FOR AN X-RAY. THE DR CONFIRMED THE PATIENT WAS FINE AND NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE DR STATED THERE WERE NO CHANGES IN THE PATIENT'S CONDITION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290087 HENRY SCHEIN INC CARBIDE ROTARY DENTAL BUR EJL PRIMA DENTAL GROUP CSET02G10FZ775X 1165450

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O