BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUTTA-PERCHA PLUGGER

    MDR report key: 7793542 · Received August 17, 2018

    Report

    Report Number
    8031010-2018-00083
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Report Date
    August 28, 2018
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED PLUGGER HAS ONE OF TIP (#2) WHICH IS ACTUALLY BROKEN IN THE SECOND DEPTH RING. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. ROOT CAUSES ARE NOT IDENTIFIED. THIS KIND OF EVENT IS TRACKED AND WE MONITOR THE TREND.

    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. 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 PLUGGER BROKE DURING USE; NO INJURY RESULTED AND THE SEPARATED PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636418 GUTTA-PERCHA PLUGGER PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1