BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GT FIBER POST 1.25MM

    MDR report key: 8471614 · Received April 1, 2019

    Report

    Report Number
    2320721-2019-00057
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Report Date
    March 30, 2019
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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 WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GT FIBER POST BROKE DURING USE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263716 GT FIBER POST 1.25MM POST, ROOT CANAL ELR TULSA DENTAL PRODUCTS LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1