BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 15360341 · Received September 6, 2022

    Report

    Report Number
    9611053-2022-00622
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Report Date
    October 18, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION FOUND: NC073292/CA-SN:(B)(6):MICROMOTOR GMR2086025 AND CONTRA ANGLE 143217 (2020) CAN NO LONGER BE SEPARATED. (IF THE CLEANING PROCESS IS NOT CHECKED FOR YEARS, THEN THE ASSEMBLY WILL CORRODE, OR AFTER AN IMPACT, IN THIS CASE, THE MICROMOTOR WILL BEND AND CAN NO LONGER BE SEPARATED). THEREFORE, PLEASE CHECK YOUR CARE AND CLEANING PROCESS. REPLACED WITH GMR2297029 AND WITH CONTRA ANGLE SN:(B)(6). FUNCTION TEST WITHOUT ERROR. CUSTOMER MISUSE/ABUSE. CONTRA ANGLE AND MOTOR CORRODED DUE TO LESS MAINTENANCE. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT VDW GOLD/SILVER WON'T HOLD FILES. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134992 WST 6:1 F. VDW.GOLD/SILVER HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown