BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASTE FILLER

    MDR report key: 6373782 · Received March 2, 2017

    Report

    Report Number
    8031010-2017-00011
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Report Date
    April 12, 2017
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVOLVED ROOT FILLERS WHICH WERE RETURNED HAVE BEEN ANALYZED. ONE OF THEM IS ACTUALLY BROKEN AT THE BASE OF THE ACTIVE PART AND NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. THE SECOND INSTRUMENT IS UNSCATHED WITHOUT VISIBLE MARKS OF USE. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW. NO UNUSED PRODUCT HAVE BEEN RETURNED FOR EVALUATION. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 1

    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 PASTE FILLER SEPARATED AFTER INITIAL USE. THE BROKEN PART WAS RETRIEVED AND THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153948 PASTE FILLER INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY MAILLEFER NA 1279419

    Patients

    Seq Age Sex Outcome Treatment
    1