BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACHTOU PLUGGER 001/002

    MDR report key: 7151150 · Received December 28, 2017

    Report

    Report Number
    9611053-2017-00094
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Report Date
    February 23, 2018
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH THE SAME PRODUCT WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT 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.

    Additional Manufacturer Narrative · 1

    THE ACTIVE PART #1 OF THE RETURNED PLUGGER IS ACTUALLY BROKEN IN THE MIDDLE DEPTH RING. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. ACTIVE PART #2 IS NOT DAMAGED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. FOR INFORMATION, MSA RECOMMENDS TO DO NOT APPLY A TOO HIGH BENDING FORCE DURING THE USE OF THIS INSTRUMENT.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A MACHTOU PLUGGER SEPARATED; THE BROKEN PIECE HAS BEEN RETRIEVED. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929464 MACHTOU PLUGGER 001/002 PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY VDW GMBH NA 8433910

    Patients

    Seq Age Sex Outcome Treatment
    1