BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASE RX SGL 022/LL7 -30T -1A 4D

    MDR report key: 8233396 · Received January 10, 2019

    Report

    Report Number
    2418500-2018-00001
    Event Type
    Injury
    Date Received
    January 10, 2019
    Report Date
    April 18, 2019
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    DZD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE INTERVENTION WAS REQUIRED, 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.

    Description of Event or Problem · 1

    A DOCTOR CLAIMS THAT THE NEW BASE RX SKUS HAVE A LOWER PROFILE AND AS A RESULT THEY ARE SEEING AN UNWANTED ERUPTION OF THE MOLARS AND THIS IS PROLONGING TREATMENT TIMES FOR THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31139 BASE RX SGL 022/LL7 -30T -1A 4D TUBE, ORTHODONTIC DZD DENTSPLY SIRONA ORTHODONTICS INC. NA 00135290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention