BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT FILLER L

    MDR report key: 7366874 · Received March 23, 2018

    Report

    Report Number
    9611053-2018-00030
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    May 22, 2018
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT WITH THE SAME PRODUCT 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. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PASTE FILLER RETURNED IN LOOSE IS ACTUALLY BROKEN AT THE BASE OF THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW. UNUSED INSTRUMENTS WERE MEASURED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. FOR INFORMATION, NO MECHANICAL TEST IS APPLICABLE REGARDING THIS PRODUCT. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BROKEN PIECE WAS EASILY RETRIEVED AND NO INJURY RESULTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208306 ROOT FILLER L INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY VDW GMBH NA 103253

    Patients

    Seq Age Sex Outcome Treatment
    1