BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 9330457 · Received November 15, 2019

    Report

    Report Number
    9611053-2019-00402
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Report Date
    September 17, 2020
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    BATTERY (WAS CHARGED 192 TIMES WITH AN OPERATING TIME OF 22:29:41 HOURS, WHEREBY 12 CHARGING CYCLES WOULD HAVE BEEN SUFFICIENT) DEFECTIVE. DEFECTIVE DISPLAY GLASS (BROKEN BRACKET), MICROMOTOR SMR 1241917, CONTRA-ANGLE 45664 AND FOOT CONTROL 70007 WITHOUT RECOGNIZABLE ERRORS. NOTE: THE COVID-19 PANDEMIC CAUSED A DISRUPTION IN NORMAL BUSINESS ACTIVITIES, RESULTING IN LATE SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY SIRONA. 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

    IN THIS EVENT IT WAS REPORTED THAT A SILVER RECIPROC MOTOR SUDDENLY STOPS DURING USE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120213 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1