BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW GOLD/SILVER CONTRA ANGLE

    MDR report key: 9137821 · Received September 30, 2019

    Report

    Report Number
    9611053-2019-00324
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Report Date
    September 14, 2020
    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 · 0

    PLEASE NOTE, THE INCORRECT MANUFACTURER (G1) WAS INADVERTENTLY REPORTED IN THE INITIAL SUBMISSION. SEE CORRECTED MANUFACTURER IN (G1) OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    SN: (B)(6) :COTRA ANGLE 103559 (2017) (PRESSURE COVER AND HEAD DRIVE) REPLACED. FOOT CONTROL 142636 AND GMR1765020 CHECKED. WITHOUT POWER CORD AND FILE CLAMP AND CABLE. FUNCTION TEST AND TEST MEASUREMENTS WITHOUT ERRORS.

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO PREVIOUS REPORTS WITH THIS OR A SIMILAR DEVICE WHERE THIS MALFUNCTION CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE SUCH, BUT FDA IS REQUIRING REPORTING SINCE 21ST MAY 2019. AS SUCH, THIS EVENT 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 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 CONTRA ANGLE 6:1 FOR VDW.GOLD/SILVER WOULD NOT HOLD FILES; NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931716 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