BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE, 4X, STERILE

    MDR report key: 20155573 · Received September 6, 2024

    Report

    Report Number
    9611053-2024-00159
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Report Date
    December 9, 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

    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 WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1830600, #1832421, #1831029, #1833836, #1833069, #1833834, #1835591 AND #1835592). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, EXCESSIVE WEAR, OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE).

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A RECIPROC BLUE, 4X, STERILE BROKE DURING USE. THE BROKEN PART REMAINS INSIDE THE TOOTH, NO ADDITIONAL TREATMENT IS NEEDED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034975 RECIPROC BLUE, 4X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 428296

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown