BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 9572871 · Received January 9, 2020

    Report

    Report Number
    9611053-2019-00477
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    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 (VOLTAGE BREAKS DOWN UNDER LOAD) DEFECTIVE, THE MICROMOTOR SMR113560, FOOT CONTROL 69065 AND THE SIRONA CONTRA-ANGLE 07776 ARE NOT DEFECTIVE. NOTE: THE COVID-19 PANDEMIC CAUSED A DISRUPTION IN NORMAL BUSINESS ACTIVITIES, RESULTING IN LATE SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE STALLING HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. 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
    36133 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1