BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIDWEST TRADITION HANDPIECE

    MDR report key: 11758366 · Received April 30, 2021

    Report

    Report Number
    9614977-2021-00012
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Report Date
    June 9, 2021
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Product Code
    EFB
    PMA / PMN Number
    K131319
    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

    ADDITIONAL SERIAL NUMBERS INCLUDED IN THIS REPORT: (B)(4). 5 OF 13 DEVICES WERE RETURNED FOR EVALUATION. WE ARE AWAITING THE RETURN OF 8 DEVICES. EVALUATION OF 4 DEVICES FOUND NORMAL CHUCK WEAR AND THE TURBINES NEEDED TO BE REPLACED. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS. EVALUATION OF 1 DEVICE FOUND CHUCK WEAR AND LACK OF MAINTENANCE. THE DEVICE WAS CLEANED OF DEBRIS AND THE TURBINE WAS REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 13 MALFUNCTION EVENTS WHERE A MIDWEST TRADITION HANDPIECE WOULD NOT HOLD BURS. NO INJURY RESULTED IN ANY OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649984 MIDWEST TRADITION HANDPIECE HANDPIECE, AIR-POWERED, DENTAL EFB SIRONA DENTAL SYSTEMS GMBH 803574, 11895, 4543, 17929

    Patients

    Seq Age Sex Outcome Treatment
    1