BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN

    MDR report key: 23142482 · Received September 25, 2025

    Report

    Report Number
    3003444492-2025-00005
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 25, 2025
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HENRY SCHEIN INC - HSI CONTROL NUMBER: (B)(6) - HSI ITEM NUMBER: 5700190 - PRIMA PART NUMBER: 103310 - LOT: 1615592 - WILL NOT CUT ANYTHING, CAN'T CUT CROWN. 1. HAS A SERIOUS PUBLIC HEALTH THREAT OCCURRED? NO - 2. HAS A DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH OCCURRED? NO. 1. WAS THERE PATIENT/USER INVOLVEMENT? YES, THERE WERE MANY TIMES THAT WE STARTED TO DRILL ON BONE OR TOOTH, AND IT BREAKS, VERY LITTLE PRESSURE WAS APPLIED. 2. IS THERE ANY RECORDED PATIENT/USER INJURY/HARM? YES (DR. (B)(6)' PATIENT, PRODUCT BROKEN BUR UNDER FLAP). 3. IS THERE ANY FOLLOW-UP INTERVENTION/TREATMENT REQUIRED FOR THE PATIENT/USER? STILL PENDING, WE MAY HAVE TO PAY ANOTHER SURGEON TO REMOVE. 4. HAVE ANY REPORTING TO AUTHORITIES/FIELD SAFETY RELATED ACTIVITIES BEEN INITIATED BY THE CUSTOMER OR THE USER? YES, REPORT MADE TO MEDWATCH. 5. PLEASE PROVIDE INFORMATION ON THE HANDPIECE USED. (BRAND/MODEL) - X CUBE MOTORS WITH RAM STRAIGHT HANDPIECES 1:1. 6. WAS THE DEVICE CLEANED/RE-PROCESSED PRIOR TO USAGE? IF SO, HOW MANY TIMES (IF KNOWN). WE ONLY USE BURS ONCE, BRAND NEW FOR EVERY PT.

    Description of Event or Problem · 0

    DURING A PROCEDURE THE BUR WAS BEING USED IN AN X CUBE MOTORS WITH RAM STRAIGHT HANDPIECE WHEN IT BROKE AND REMAINED IN A PATIENT'S MOUTH. THE PATIENT MAY NEED TO GO FOR AN ADDITIONAL PROCEDURE TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504139 HENRY SCHEIN CARBIDE BUR HP 703, EJL PRIMA DENTAL GROUP 103310 1615592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O