BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E4D DENTIST

    MDR report key: 990799 · Received January 30, 2008

    Report

    Report Number
    3004998675-2008-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 3, 2008
    Manufacturer
    D4D TECHNOLOGIES, LLC
    Product Code
    NOF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL PERFORMANCE AND REVIEW OF STAND-OFF AND BOOTIE: CLINICAL EVALUATION TO DETERMINE IF THE DESIGN SPECIFICATIONS AND RESULTING PRODUCT (BOOTIE AND STANDOFF) MET OR EXCEEDED CLINICAL PERFORMANCE ACCORDING TO INSTRUCTIONS FOR USE AND NORMAL OPERATING CONDITIONS. IN 2008, A NEW CLINICAL OPERATOR WAS OBSERVED UTILIZING ALL SIZES OF THE BOOTIE (6MM, 8MM, 10MM) TO SCAN ANTERIOR AND POSTERIOR PREPARATIONS. NO ADD'L INSTRUCTION WAS GIVEN. THE OPERATOR PERFORMED OVER 100 SCANS WITHOUT ANY INCIDENCE OF THE BOOTIES COMING LOOSE OR DISLODGING. IN SOME CASES, A SINGLE SET OF BOOTIES WAS USED TO PERFORM 30 CONSECUTIVE SCANS. THREE DAYS LATER, AN EXPERIENCED CLINICAL OPERATOR PERFORMED SEVERAL SETS (9) OF CLINICAL SCANS ON THE MOST DISTAL TOOTH (#31) USING THE YELLOW BOOTIES IN THE LOWER ARCH. NO DISLODGEMENT OCCURRED DURING ROTATIONS AND NO DISCOMFORT WAS OBSERVED BY THE PT. REVIEW OF CLINICAL RESULTS, SUPPORT CALLS AND QUESTIONNAIRES OF EXISTING ECO MEMBERS (D4D CLINICAL OPERATORS) REVEALED ONLY ONE INCIDENCE OF REPORTING BY AN OBSERVER THAT THE BOOTIES CAME OFF DURING OPERATION AND WERE A NON-ISSUE TO THE PT. CLINICAL SUMMARY: THROUGH INITIAL BUT EXTENSIVE USE OF THE BOOTIES OF VARIOUS SIZES, WHEN USED UNDER NORMAL AND INSTRUCTED OPERATING CONDITIONS, THE BOOTIES MEET THE CLINICAL REQUIREMENTS AS DESIGNED. INSTRUCTIONS FOR USE AND CLINICAL DEMONSTRATION WILL ALERT THE CLINICIAN OF POSSIBLE HAZARDS RELATED TO THE BOOT AND THE PROPER TECHNIQUES TO USE IN ORDER TO MINIMIZE THESE HAZARDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE RUBBER BOOTS ON THE STANDOFF CAME OFF DURING THE INTRA ORAL SCANNING PROCESS AND THE PT SWALLOWED THE PIECE BEFORE IT COULD BE RETRIEVED BY THE DENTIST. THERE WAS NO INJURY AND THE BOOT WAS REPLACED AND THE PROCEDURE COMPLETED. THE PT DID NOT CONSULT A PHYSICIAN AND FOLLOW UP BY THE DENTIST DID NOT REVEAL ANY HEALTH ISSUES. IT WAS ASSUMED THE PIECE HAD BEEN PASSED THROUGH THE INTESTINAL TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E4D DENTIST NOF D4D TECHNOLOGIES, LLC E4D-DOS1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR