BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIDWEST STYLUS PLUS

    MDR report key: 11758365 · Received April 30, 2021

    Report

    Report Number
    9614977-2021-00018
    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). 2 OF 12 DEVICES WERE RETURNED FOR EVALUATION. WE ARE AWAITING THE RETURN OF 10 DEVICES. EVALUATION OF 2 DEVICES FOUND NORMAL CHUCK WEAR AND THE TURBINES NEEDED TO BE REPLACED. THE DEVICES WERE REPAIRED AND RETURNED TO THE CUSTOMERS.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS WHERE A MIDWEST STYLUS PLUS HANDPIECE WOULD NOT HOLD BURS. NO INJURY RESULTED IN ANY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649987 MIDWEST STYLUS PLUS HANDPIECE, AIR-POWERED, DENTAL EFB SIRONA DENTAL SYSTEMS GMBH 4046, 2536, 5113, 5575, 8834

    Patients

    Seq Age Sex Outcome Treatment
    1