BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-POST

    MDR report key: 8596251 · Received May 9, 2019

    Report

    Report Number
    8031010-2019-00050
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    July 11, 2019
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED 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 AN X-POST REFILL BROKE IN THE TOOTH. THE PATIENT'S TOOTH WAS EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387389 X-POST POST, ROOT CANAL ELR DENTSPLY MAILLEFER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability