BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW.ROTATE 15.04 6-FILES 25MM

    MDR report key: 18099951 · Received November 9, 2023

    Report

    Report Number
    9611053-2023-00875
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Report Date
    December 8, 2023
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVOLVED PRODUCT BROKEN DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCH #1781086). THE UNUSED VDW. ROTATE 15.04 FILE 25MM WAS EVALUATED AND WAS FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    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 VDW.ROTATE 15.04 6-FILES 25MM FILE BROKE DURING USE. THE BROKEN PART REMAINS. FURTHER TREATMENT WAS DONE; A RHIZOTOMY WAS PERFORMED TO RESOLVE THE PROBLEM, DUE TO THE FEW PROSTHETIC ALTERNATIVES AND THE CLIENT'S REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73573 VDW.ROTATE 15.04 6-FILES 25MM FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 398788

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown