BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 11522067 · Received March 18, 2021

    Report

    Report Number
    9611053-2021-00079
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Report Date
    March 18, 2021
    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

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, CALIBRATION RELATED ISSUES IN ENDO MOTORS HAVE LED TO FILE SEPARATION IN THE PAST. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. CONTRA ANGLE 141669 (2019) (NECK DRIVE LOOSE) WAS ATTACHED. MICROMOTOR SMR2081405 AND FOOT CONTROL 186193 TESTED, WITHOUT ERRORS.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A VDW.SILVER RECIPROC CAUSES ERROR CODE 2 AT CALIBRATION. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411297 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1