BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENTULO RA 21MM 2

    MDR report key: 9203253 · Received October 17, 2019

    Report

    Report Number
    2320721-2019-00206
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Report Date
    January 15, 2020
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVOLVED PRODUCTS THAT BROKE DURING USE WERE NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED GATE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1283483 AND #1324846). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.

    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. THIS REPORT IS FOR THE FIRST DEVICE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED TWO GATES FILE LENTULO RA 21MM 2 BROKE DURING INITIAL USE. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000235 LENTULO RA 21MM 2 INSTRUMENT, FILLING, PLASTIC, DENTAL EIY TULSA DENTAL PRODUCTS LLC NA 1283483

    Patients

    Seq Age Sex Outcome Treatment
    1