BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 6X

    MDR report key: 21550311 · Received March 7, 2025

    Report

    Report Number
    9611053-2025-00025
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Report Date
    April 10, 2025
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED RECIPROC FILE R25 8/100 25MM 025 IS BROKEN AT THE TIP OF THE ACTIVE PART (TORQUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1863184). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ROOT CAUSES ARE NOT IDENTIFIED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    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 21 CFR 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 RECIPROC FILES 6X FILE BROKE DURING USE. THE BROKEN PART STILL REMAINS IN THE ROOT CANAL. FURTHER TREATMENT WILL BE CANAL WILL BE FILLED WITH BROKEN PART AS PATIENT IS PAIN FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280404 RECIPROC FILES 6X FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 1863184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown