BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    MDR report key: 20007646 · Received August 20, 2024

    Report

    Report Number
    8031010-2024-00104
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Report Date
    September 20, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    AN UNUSED WAVEONE GOLD PRIMARY FILE 25MM WAS RETURNED. INVOLVED PRODUCTS THAT BROKE DURING USE WERE NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH#: 1852469). THE UNUSED FILE RETURNED WAS EVALUATED AND WAS FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 25MM BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. REPORTEDLY, NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372360 WAVEONE GOLD PRIMARY 3-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown