BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 10382391 · Received August 7, 2020

    Report

    Report Number
    9611053-2020-00192
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Report Date
    August 7, 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 · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR 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 (B)(4). BATTERY (WAS CHARGED WITH AN OPERATING TIME OF 18.35.13 HOURS, 360 X, WHEREBY 9 CHARGING CYCLES WOULD HAVE BEEN SUFFICIENT) DEFECTIVE, REPLACED. MICROMOTOR (B)(4), CONTRA-ANGLE 05959 (2007) AND FOOT CONTROL 07073 CHECKED, WITHOUT ERRORS. THE HOUSING HAS CRACKED IN SEVERAL PLACES (PROBABLY DUE TO A FALL) HAS NO EFFECT ON THE FUNCTION. WE, VDW GMBH, DECLARE HEREWITH THAT THE VDW SILVER S/N (B)(4) WITH SOFTWARE (B)(4), MICROMOTOR S/N (B)(4) AND TEST CONTRA ANGLE S/N (B)(4) DOES NOT MEETS THE SPECIFICATION CONCERNING THE TORQUE LIMITATION FUNCTION IN ROTARY MOVEMENT AND RECIPROCATING MOVEMENT. THE TORQUE LIMITATION FUNCTION WAS VERIFIED WITH OUR VDW MOTOR TEST BENCH (P/N 853-093-000-011, S/N (B)(4)).

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A SILVER MOTOR HAS AN INCORRECT TORQUE AND CAUSED FILE BREAKAGE. THE FRAGMENT STILL REMAINS IN A PATIENT'S ROOT CANAL. THE FRAGMENT WILL BE REMOVED AT THE NEXT APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845155 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1