BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 14073631 · Received April 11, 2022

    Report

    Report Number
    9611053-2022-00524
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Report Date
    April 11, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT RECIPROC BLUE FILES, 6X, STERILE FILE BROKE DURING USE. BROKEN PART REMAINED IN TOOTH AND TREATMENT NOT YET CONCLUDED. REPORTED THAT INSTRUMENTS ARE NOT REMOVABLE. DENTIST WILL OBSERVE TOOTH AND WILL INFORMED IF TREATMENT STATUS CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445084 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown