BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM

    MDR report key: 8802740 · Received July 18, 2019

    Report

    Report Number
    2320721-2019-00140
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    October 3, 2019
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A WAVEONE GOLD SIZE PRIME 25 FILE BROKE DURING USE. THE FILE WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597512 WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE, PULP CANAL, ENDODONTIC EKS TULSA DENTAL PRODUCTS LLC NA 0000217928

    Patients

    Seq Age Sex Outcome Treatment
    1