BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-POST

    MDR report key: 8577908 · Received May 3, 2019

    Report

    Report Number
    8031010-2019-00043
    Event Type
    Injury
    Date Received
    May 3, 2019
    Report Date
    July 10, 2019
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE TEETH HAD TO BE REMOVED AFTER THE PINS WERE FRACTURED. 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

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED 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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT AN X-POST REFILL BROKE IN THE TOOTH. THE OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372302 X-POST POST, ROOT CANAL ELR DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1