BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYPEX 6

    MDR report key: 12933617 · Received December 6, 2021

    Report

    Report Number
    9611053-2021-00426
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Report Date
    January 12, 2022
    Manufacturer
    VDW GMBH
    Product Code
    LQY
    PMA / PMN Number
    K131907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    RAYPEX 6 PROVIDED INCORRECT MEASUREMENTS, 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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT A COMPLAINT FROM A CUSTOMER EXPERIENCED INACCURATE MEASUREMENTS WHILE USING A RAYPEX 6. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829930 RAYPEX 6 LOCATOR, ROOT APEX LQY VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown