BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBIDE BUR CAVITY ROUND FG012

    MDR report key: 24912734 · Received April 17, 2026

    Report

    Report Number
    8031010-2026-00047
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 17, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EJL
    UDI-DI
    J003E0123341012001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED BUR IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH # 1944222). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE (NUMBER OF USES NOT COMMUNICATED), EXCESSIVE WEAR, PATIENT CONDITION AND BEHAVIOR DURING TREATMENT OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). IN ADDITION, THERE ARE FURTHER CIRCUMSTANCES ON THE CONDITIONS IN DENTISTRY (USED DISINFECTANTS, TRAINING/KNOWLEDGE STATUS), OR ANY OTHER ENVIRONMENTAL CONDITIONS, WHICH ARE UNKNOWN TO US AND MAY ALSO HAVE AN IMPACT ON THE REPORTED FAILURE MODE. ROOT CAUSES ARE NOT IDENTIFIED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A CARBIDE BUR CAVITY ROUND FG012 BUR BROKE DURING USE. THE BROKEN PART FELL INTO THE PATIENT'S ORAL CAVITY. THE BROKEN PART WAS FOUND AND RETRIEVED PROMPTLY USING FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80359 CARBIDE BUR CAVITY ROUND FG012 BUR, DENTAL EJL MAILLEFER INSTRUMENTS HOLDING SARL 1944222 J003E0123341012001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown