BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GT SMALL DRILL

    MDR report key: 8700786 · Received June 14, 2019

    Report

    Report Number
    2320721-2019-00114
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Report Date
    October 3, 2019
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    ELR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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

    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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GT DRILL BROKE DURING USE. THE BROKEN PIECE WAS RETRIEVED AND NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492033 GT SMALL DRILL POST, ROOT CANAL ELR TULSA DENTAL PRODUCTS LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1