BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIDWEST TRADITION HANDPIECE

    MDR report key: 11758356 · Received April 30, 2021

    Report

    Report Number
    9614977-2021-00007
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Report Date
    June 9, 2021
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Product Code
    EFB
    PMA / PMN Number
    K963050
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN FIELD D3 WAS INADVERTENTLY MISSED DURING THE INITIAL SUBMISSION. THIS SUBMISSION IS TO CORRECT THE REPORT TO INCLUDE THIS ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    1 OF 1 DEVICE WAS RETURNED FOR EVALUATION. EVALUATION OF 1 DEVICE FOUND NORMAL CHUCK WEAR AND THE TURBINE NEEDED TO BE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST TRADITION HANDPIECE WOULD NOT HOLD BURS. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649716 MIDWEST TRADITION HANDPIECE HANDPIECE, AIR-POWERED, DENTAL EFB SIRONA DENTAL SYSTEMS GMBH ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1