BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENTULO RA 25MM 1

    MDR report key: 21619170 · Received March 17, 2025

    Report

    Report Number
    8031010-2025-00029
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Report Date
    April 1, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE UNUSED LENTULO PASTE CARRIERS' RA 25 MM 1 WERE RETURNED. INVOLVED INSTRUMENT THAT BROKE DURING USE IS NOT AVAILABLE AND CANNOT BE ANALYZED BY OUR LABORATORY. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1890142). UNUSED PASTE CARRIERS ARE VISUALLY CONFORMING AND WITHOUT MATERIAL OR MACHINING DEFECT LIKELY TO WEAKEN THE INSTRUMENTS FOR INFORMATION NO MECHANICAL TEST IS APPLICABLE FOR LENTULO INSTRUMENTS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A LENTULO RA 25MM 1 BROKE DURING USE. THE BROKEN PART REMAINS IN THE TOOTH, HAS NOT BEEN RETRIEVED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283466 LENTULO RA 25MM 1 FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1890142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown