BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 6-FILE STER 25MM

    MDR report key: 17449815 · Received August 3, 2023

    Report

    Report Number
    8031010-2023-00822
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Report Date
    September 8, 2023
    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

    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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE IS NOT AVAILABLE AND CANNOT BE ANALYZED BY OUR LABORATORY. MOREOVER, THE BATCH NUMBER FROM WHICH THE BROKEN FILE IS ORIGINATING REMAINS INCERTAIN. NOTABLY FOR THIS REASON, NO LINK CAN BE ESTABLISHED BETWEEN BREAKAGE ISSUE AND INFORMATION FOUND DURING DHRS REVIEW (BATCHES #1813553 AND #1812202). PER BOUNDING WITH PREVIOUS COMPLAINT (B)(4), SOME AVAILABLE UNUSED FILES FROM BATCHES #1813553 AND #1812202 HAD BEEN EVALUATED AND HAD BEEN FOUND IN COMPLIANCE WITH SPECIFICATIONS. ACCORDING TO OUR PRESCRIPTIONS, WE CAN CONSIDER THAT THE PRODUCTIONS BATCHES #1813553 AND #1812202 ARE CONFORMING (REPRESENTATIVE SAMPLINGS). NO FAULT WAS FOUND, PRODUCTIONS MEET SPECIFICATIONS.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25MM BROKE DURING USE. REPORTEDLY, THE BROKEN PARTS WERE NOT RETRIEVED. THE PATIENT IS SYMPTOM FREE AND NO FURTHER INTERVENTION IS NECESSARY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325020 WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1813553, 1812202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown