BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 15880470 · Received November 29, 2022

    Report

    Report Number
    9611053-2022-00683
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Report Date
    January 4, 2023
    Manufacturer
    VDW GMBH
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTRA-ANGLE 110946(2017) (BROKEN FILE IN THE HEAD) DEFECTIVE, REPAIRED. FUNCTIONAL TESTING WITHOUT ERRORS. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED 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 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT WST 6:1 F. VDW.GOLD/SILVER WAS RETURNED WITH A BROKEN FILE INSIDE. NO INFORMATION REGARDING INJURY OR INFORMATION RECEIVED. REQUESTED FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430116 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