BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V041113000000

    MDR report key: 14469137 · Received May 23, 2022

    Report

    Report Number
    9611053-2022-00557
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Report Date
    July 6, 2022
    Manufacturer
    VDW GMBH
    Product Code
    LQY
    PMA / PMN Number
    K131907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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 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

    FILECLIP ( BROKEN / RIPPED WIRE ) DEFECTIVE, REPLACED. MEASURMENT CABLE AND CHARGER CHECKED, WITHOUT ERROR. FUNCTIONAL TEST WITHOUT ERROR.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A RAYPEX 6 GAVE INCORRECT MEASUREMENTS, NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145535 V041113000000 LOCATOR, ROOT APEX LQY VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown