BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE, 4X, STERILE

    MDR report key: 18355147 · Received December 19, 2023

    Report

    Report Number
    9611053-2023-00893
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Report Date
    February 28, 2024
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE BROKEN PARTS WERE INCORPORATED INTO THE FILLING. NO INJURY. SUMMARY: INVOLVED PRODUCTS THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE IDENTIFIED AND ANALYZED. MOREOVER, NO UNUSED FILES ARE AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1770455, #1770456, #1770319 AND #1770133). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE - 4580 HEALTH EFFECT - IMPACT CODE - 4648 THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 3165 HEALTH EFFECT - IMPACT CODE - 2199 THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    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 RECIPROC BLUE, 4X, STERILE 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
    1164641 RECIPROC BLUE, 4X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 393458

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown