BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK MAILLEFER

    MDR report key: 15751436 · Received November 8, 2022

    Report

    Report Number
    8031010-2022-00684
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    August 20, 2022
    Report Date
    December 19, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE FORMALLY IDENTIFIED AND ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. THE PROVIDED BATCH #1913023 HAS NO CORRESPONDING IN OUR SYSTEM (DOES NOT EXIST). THE RIGHT BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. 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 PROTAPER NEXT X2 FILE BROKE DURING USE. THE BROKEN PIECE WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377537 UNK MAILLEFER FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1913023

    Patients

    Seq Age Sex Outcome Treatment
    1 Female