BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBEL BIOCARE

    MDR report key: 939383 · Received November 5, 2007

    Report

    Report Number
    MW5004340
    Event Type
    Injury
    Date Received
    November 5, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 5, 2007
    Manufacturer
    NOBEL BIOCARE USA
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    OVER THE PAST 4 MONTHS WE HAVE OBSERVED A REPEATED PRODUCT FAILURE IN THE ESTHETIC CERAMIC ABUTMENTS FOR THE NOBEL BIOCARE REPLACE SELECT DENTAL IMPLANTS -- PRODUCT #29252 AND # 29256. THE FAILURE RESULTS WHEN THE BOND BETWEEN THE METAL SUBSTRATE/BASE AND THE CERAMIC FAILS AND THE TWO COMPONENTS SEPARATE FROM ONE ANOTHER. THIS RESULTS IN COMPLETE LOSS OF THE SUPPORTED RESTORATION AND PLACES THEPATIENT/CLINICIAN/LABORATORY UNDER A SIGNIFICANT FINANCIAL LIABILITY. I HAVE CONTACTED BOTH MY LOCAL AREA REPRESENTATIVE NOBEL BIOCARE'S TECHNICAL SUPPORT OFFICE IN REGARD TO THIS MATTER BUT HAVE NOT BEEN GIVEN ANY CONSIDERATION WHATSOEVER. I AM INFORMED THAT A TECHNICIAN, A CERTIFIED DENTAL TECHNICIAN, WILL GET BACK WITH ME TO DISCUSS THE MATTER FURTHER. HOWEVER, NO ONE HAS EVER TRIED TO RETURN MY CALLS OR OFFER ANY TECHNICAL GUIDANCE WITH RESPECT TO THE ONGOING PRODUCT FAILURES. AS THIS IS NOT A SINGLE-OCCURRENCE EVENT AND IT HAS OCCURRED WITH CERAMIC ABUTMENTS PLACED SEVERAL YEARS AGO AS WELL AS CERAMIC ABUTMENTS PLACED WITHIN THE PAST YEAR. ADDITIONALLY, TWO DIFFERENT LABS AND THREE DIFFERENT RESTORATIVE DENTISTS HAVE BEEN INVOLVED IN THESE FAILURES SUGGESTING, SO IT DOES NOT APPEAR TO BE "OPERATOR-SPECIFIC". ALL PARTIES INVOLVED IN THE PT'S CARE FOLLOWED THE RECOMMENDED PROTOCOL AND USED CERTIFIED COMPONENTS AT ALL STEPS IN MANUFACTURING AND RESTORATION OF THE IMPLANTS. THE BIGGEST CONCERN IS THE IMPACT IT HAS ON OUR PATIENTS. WE TYPICALLY USE CERAMIC ABUTMENTS IN THOSE CLINICAL SITUATIONS WHERE THE ESTHETIC DEMANDS ARE VERY HIGH, USUALLY AN UPPER FRONT TOOTH. THUS, YOU CAN APPRECIATE THE PANIC AND FRUSTRATION THESE PATIENTS HAVE WHEN AN ANTERIOR RESTORATION LITERALLY "FALLS OUT" LEAVING THEM TOOTHLESS. THIS IS IN ESSENCE A "DENTAL EMERGENCY" WHICH MUST BE HANDLED PROMPTLY AND THUS PROVES DISRUPTIVE TO BOTH THE CLINICIAN AND THE PATIENT'S SCHEDULE AND PLANNED ENDEAVORS. THUS FAILURE OF THE PRODUCT NOT ONLY RESULTS IN HUNDREDS, IF NOT THOUSANDS OF DOLLARS IN ADDITIONAL COSTS, BUT IS IMMENSELY FRUSTRATING TO ALL PARTIES. YOUR REVIEW OF THIS CONCERN IS APPRECIATED. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: REPLACEMENT OF MISSING TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOBEL BIOCARE ESTHETIC CERAMIC ABUTMENT DZE NOBEL BIOCARE USA
    2 NOBEL BIOCARE ESTHETIC CERAMIC ABUTMENT DZE NOBEL BIOCARE USA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention