BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT FILLER -L-, STERILE

    MDR report key: 10916508 · Received November 29, 2020

    Report

    Report Number
    9611053-2020-00367
    Event Type
    Malfunction
    Date Received
    November 29, 2020
    Report Date
    January 30, 2021
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED PASTE FILLERS THAT HAVE BROKEN DURING USE HAVE NOT BEEN RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1455636, #1478554 AND #1477871). THE UNUSED PASTE FILLERS 25MM N°2 RETURNED HAVE BEEN MEASURED AND HAVE BEEN 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. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.

    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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT PASTE FILLERS OF A CERTAIN LOT ARE SEPARATING. NO INJURY REPORTED. THE OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381706 ROOT FILLER -L-, STERILE INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY VDW GMBH NA 264710

    Patients

    Seq Age Sex Outcome Treatment
    1