BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROOT FILLER L

    MDR report key: 4658886 · Received April 1, 2015

    Report

    Report Number
    8031010-2015-00007
    Event Type
    Malfunction
    Date Received
    April 1, 2015
    Report Date
    February 20, 2015
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EIY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. INVOLVED ROOT FILLERS WHICH WERE RETURNED OUT FROM THE BLISTERS HAVE BEEN ANALYZED . ONE OF THEM IS ACTUALLY BROKEN IN THE ACTIVE PART AND NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. THE TWO OTHER INSTRUMENTS ARE UNSCATHED WITHOUT VISIBLE MARKS OF USE. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW. A SAMPLE OF 10 UNUSED DEVICE WAS MEASURED AND WAS FOUND IN COMPLIANCE WITH SPEC. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PASTE FILLER SEPARATED; THE BROKEN PART REMAINED IN ROOT CANAL AND ROOT CANAL WAS FILLED. NO FURTHER TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215433 ROOT FILLER L INSTRUMENT, FILLING, PLASTIC, DENTAL EIY DENTSPLY VDW GMBH 097662

    Patients

    Seq Age Sex Outcome Treatment
    1