BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUTTA-PERCHA PLUGGER

    MDR report key: 6408969 · Received March 16, 2017

    Report

    Report Number
    8031010-2017-00006
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Report Date
    April 12, 2017
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO PATIENT WAS INVOLVED AS THE PLUGGER BROKE DURING STERILIZATION. RETURNED PLUGGER HAS ONE OF TIP (#1) 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

    HOWEVER, 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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A MACHTOU PLUGGER SEPARATED. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191033 GUTTA-PERCHA PLUGGER PLUGGER, ROOT CANAL, ENDODONTIC EKR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1