BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACHTOU-PLUGGER 001/002

    MDR report key: 16911514 · Received May 11, 2023

    Report

    Report Number
    9611053-2023-00783
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Report Date
    May 11, 2023
    Manufacturer
    VDW GMBH
    Product Code
    EKR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE 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. THIS EVENT WILL BE RE-EVALUATED, AS APPROPRIATE, IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE INVOLVED MACHTOU PLUGGER 001/002 THAT BROKE DURING USE WAS NOT RETURNED. THROUGH THE SENT PICTURES, WE CAN SEE THAT THE TWO ACTIVE PARTS OF THE PLUGGER ARE BROKEN AT THE BASE, AT THE LAST DEPTH MARK LEVEL. NO FURTHER ANALYSIS CAN BE PERFORMED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1795895). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT MACHTOU-PLUGGER 001/002 BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR; FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916022 MACHTOU-PLUGGER 001/002 PLUGGER, ROOT CANAL, ENDODONTIC EKR VDW GMBH 1795895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown