BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW GOLD/SILVER CONTRA ANGLE

    MDR report key: 11319769 · Received February 11, 2021

    Report

    Report Number
    9611053-2021-00010
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Report Date
    February 11, 2021
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EGS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. 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. BATTERY (VOLTAGE COLLAPSES UNDER LOAD) DEFECTIVE, REPLACED. CONTRA-ANGLE HANDPIECE 92038 (2016) (NO LONGER HOLDS THE FILE) DEFECTIVE, REPLACED WITH 100487 (2017). MICRO MOTOR GMR1657836 AND FOOT CONTROL 122704 WITHOUT ERRORS. FUNCTION TEST AND TEST MEASUREMENTS WITHOUT ERRORS.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A CONTRA ANGLE 6:1 FOR VDW.GOLD/SILVER WOULD NOT HOLD FILES; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215917 VDW GOLD/SILVER CONTRA ANGLE HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1