BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT FILLER L

    MDR report key: 6063464 · Received October 28, 2016

    Report

    Report Number
    9611053-2016-00051
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Report Date
    September 20, 2016
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    DENTIST

    Narratives

    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 21 CFR PART 803. THE INVOLVED DEVICES ARE ACTUALLY BROKEN AT THE BASE OF THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. NO UNUSED ROOT FILLER IS AVAILABLE FOR EVALUATION. 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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PASTE FILLER SEPARATED; OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. HOWEVER, THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715589 ROOT FILLER L INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY VDW GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1