BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITIME EASY PUTTY

    MDR report key: 6671223 · Received June 27, 2017

    Report

    Report Number
    3011203516-2017-00004
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 20, 2017
    Report Date
    June 20, 2017
    Manufacturer
    HERAEUS KULZER SRL
    Product Code
    ELW
    PMA / PMN Number
    K000629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION # E2015010, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER SRL (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. NARRATIVE FOR METHOD, RESULTS AND CONCLUSIONS CODES: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. REVIEWED DFU, THESE INSTRUCTIONS ARE PRINTED IN BOLD TYPE AND OUTLINED: IF THERE ARE SUBSTANTIAL UNDERCUTS OR HIGHLY DIVERGENT TEETH IN THE IMPRESSION AREA, APPROPRIATE BLOCKING OUT MUST BE PERFORMED IF USING FLEXITIME HEAVY TRAY OR EASY PUTTY. H3 OTHER TEXT : NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    86 YEAR OLD FEMALE PATIENT WITH DEEP UNDERCUTS AND MOBILE MOLARS HAD A FLEXITIME EASY PUTTY IMPRESSION STUCK ON HER MANDIBULAR TEETH FOR AN HOUR. THE TRAY AND MATERIAL HAD TO BE CUT AWAY WITH A DRILL AND SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451194 FLEXITIME EASY PUTTY MATERIAL, IMPRESSION ELW HERAEUS KULZER SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention