BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACHTOU PLUGGER 001/002

    MDR report key: 8139188 · Received December 6, 2018

    Report

    Report Number
    9611053-2018-00221
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Report Date
    January 9, 2019
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTIVE PART #1 OF THE RETURNED PLUGGER IS ACTUALLY BROKEN ON THE FIRST DEPTH RING. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. ACTIVE PART #2 IS NOT DAMAGED. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. 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.

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, 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. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY (B)(4). 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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979928 MACHTOU PLUGGER 001/002 PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY VDW GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1