BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLANSCAN

    MDR report key: 6645328 · Received June 15, 2017

    Report

    Report Number
    3004998675-2017-00001
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    D4D TECHNOLOGIES, LLC
    Product Code
    NOF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PER (B)(6), ITEM THAT CRACKED WHILE IN THE PATIENTS MOUTH. BLOOD WAS UNDER THE CRACK AND WHEN THEY GOT IT OUT IT SHATTERED AT THE TIP OF THE SCREEN AND PLASTIC. (B)(6) 2017 AT 10:55 A.M. (B)(6) LEFT MESSAGE WITH (B)(4) AT FRONT DESK FOR (B)(6) TO CALL BACK. AT 3:36 P.M. CALLED AGAIN AND SPOKE WITH (B)(4) AT THE OFFICE AND (B)(6) WAS WITH PATIENTS BUT WILL BE GIVEN MESSAGE TO CAL. THEN AT 4:58 P.M. (B)(4) SPOKE WITH (B)(4) AT THE OFFICE AND SHE PROVIDED (B)(6)'S EMAIL WHICH AN E-MAIL WAS SENT FOR ADDITIONAL INFORMATION. AT 5:51 P.M. (B)(6) RESPONDED TO THE E-MAIL SENT AND PROVIDED SOME ADDITIONAL INFORMATION. SHE SAID THAT THE PART OF THE PLANSCAN SCANNER THAT CRACKED IS THE INTERNAL MIRROR AND THE EDGE OF THE OUTER RIM AT THE TIP OF THE SCANNER. THE PROCEDURE THE DOCTOR WAS PERFORMING AT THE TIME WAS INTRAORAL SCANNING FOR THE SAME DAY SEAT CROWN. SHE IS NOT AWARE OF ANY PIECES THAT FELL AS A RESULT OF THE CRACK. SHE COULD NOT SEE THE LOT NUMBER OR SERIAL NUMBER AS IT LOOKS LIKE ITS ON THE INSIDE OF THE NECK. THE PATIENT IS DOING FINE AS OF TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423902 PLANSCAN NOF - OPTICAL IMPRESSION SYSTEM FOR CAD/CAM OF DENTAL RESTORATIONS NOF D4D TECHNOLOGIES, LLC PLANSCAN SCANNER TIP - STANDARD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1