BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATES AD 32MM 3

    MDR report key: 19405021 · Received May 28, 2024

    Report

    Report Number
    2320721-2024-00035
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Report Date
    August 14, 2024
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNSUCCESSFUL ATTEMPTS TO RETRIEVE SUSPECT PRODUCT FOR INVESTIGATION/EVALUATION HAVE BEEN MADE AND DOCUMENTED. COMPLAINT WILL BE REOPENED IF SUSPECT PRODUCT OR INVESTIGATION RESULT ARRIVES PER (B)(4).

    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 A GATES AD 32MM 3 GLIDDEN DRILL BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677535 GATES AD 32MM 3 REAMER, PULP CANAL, ENDODONTIC EKP TULSA DENTAL PRODUCTS LLC 1837825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown