BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 6-FILE STER 25MM

    MDR report key: 17308269 · Received July 12, 2023

    Report

    Report Number
    8031010-2023-00811
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Report Date
    August 4, 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

    ADDITIONAL INFORMATION RECEIVED THAT BROKEN PART HAS NOT BEEN RETRIEVED AND PATIENTS ARE SYMPTOM FREE AND NO FURTHER INTERVENTION IS NECESSARY. INVESTIGATION 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).

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD PRIMARY 6-FILE STER 25MM BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803729 WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1813553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown