BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER GOLD ASSORT SX/F3 25MM STER

    MDR report key: 16564264 · Received March 17, 2023

    Report

    Report Number
    8031010-2023-00767
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Report Date
    March 31, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVOLVED FILES (PTG S1 25MM) THAT BROKE DURING USE WERE NOT RETURNED AND CANNOT BE ANALYZED (THE RETURNED PROTAPER GOLD ASSORTMENTS SX/F3 25MM CONTAIN NO PTG S1 25MM FILE). MOREOVER, NO UNUSED PTG S1 25MM FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1746971). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ADDITIONAL INFORMATION RECEIVED THAT THE BROKEN PART REMAINS IN THE ROOT CANAL. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE -4582. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE -3165.

    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 PROTAPER GOLD ASSORT SX/F3 25MM STER FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559071 PROTAPER GOLD ASSORT SX/F3 25MM STER FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1746971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown