BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAFIL PLUS OBTURATORS

    MDR report key: 3230002 · Received July 10, 2013

    Report

    Report Number
    2320721-2013-00009
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, AS OF THIS MDR EVALUATION HAS NOT BEEN RECEIVED. BECAUSE THERE IS AN INDICATION THE MEDICAL INTERVENTION WAS REQUIRED IN THIS EVENT, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT A DENTIST REPORTED THAT AFTER USING THERMAFIL PLUS AND RIBBON SEALER TO PERFORM A ROOT CANAL ON A PATIENT, THE ROOT CANAL FAILED AND THE PATIENT WAS REFERRED TO AN ENDODONTIST FOR FURTHER TREATMENT. THE ENDODONTIST TOLD THE PATIENT THAT THE ROOT CANAL FAILED BECAUSE THE DENTIST HAD USED "QUESTIONABLE MATERIALS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317869 THERMAFIL PLUS OBTURATORS EKM DENTSPLY TULSA DENTAL SPECIALTIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RIBBON ROOT CANAL SEALER