BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 6X

    MDR report key: 8737909 · Received June 26, 2019

    Report

    Report Number
    9611053-2019-00175
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Report Date
    August 21, 2019
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVOLVED RECIPROC FILE R25 8/100 25MM 025 THAT BROKE DURING USE IS NOT AVAILABLE AND CANNOT BE ANALYZED BY OUR LABORATORY. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1492881, #1499039, #1499054, #1497654, #1498803, #1499385 AND #1497672). THE UNUSED PRODUCTS HAVE BEEN EVALUATED ACCORDING TO OUR PRESCRIPTIONS AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS (MEASURES, TORQUE TEST). THE SAMPLE BEING REPRESENTATIVE, WE CAN CONSIDER THAT THE VDW BATCH #253769 IS CONFORMING. NO FAULT FOUND. PRODUCTION MEETS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    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 · 1

    IN THIS EVENT IT WAS REPORTED THAT A RECIPROC BROKE DURING USE. THE SEPARATED PIECE COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531457 RECIPROC FILES 6X FILE, PULP CANAL, ENDODONTIC EKS DENTSPLY VDW GMBH NA 253769

    Patients

    Seq Age Sex Outcome Treatment
    1