BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM

    MDR report key: 722080 · Received May 9, 2006

    Report

    Report Number
    MW1039052
    Date Received
    May 9, 2006
    Manufacturer
    3M
    Product Code
    NSP
    Report Source
    Voluntary report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    I RECENTLY RECEIVED AN ADVERTISING PIECE FROM 3M PROMOTING THEIR PARADIGM RESTORATIVE BLOCKS FOR THE CEREC CAD/CAM SYSTEM. PLEASE NOTE THAT PARADIGM IS PROMOTED FOR USE IN CASES INVOLVING BRUXERS AND HEAVY OCCLUSION. (BRUXISM IS THE HIGHLY DESTRUCTIVE PROCESS OF CLENCHING ONE'S TEETH. THE PACKAGE INSERT FOR THIS PRODUCT STATES, "PARADIGM MZ100 BLOCK IS NOT RECOMMENDED FOR BRUXERS OR CLENCHERS." THIS IS A HIGHLY IMPORTANT CONTRADICTION. WHEN I CALLED 3M FOR CLARIFICATION, THE CUSTOMER SVC REP SAID. "OH, WE MUST HAVE FORGOTTEN TO CHANGE THE PACKAGE INSERT." IF THERE IS A CONFLICT BETWEEN A MARKETING CAMPAIGN AND THE PACKAGE INSERT, IT WOULD SEEM TO ME THAT SIMPLY CHANGING THE TECHNICAL DATA TO MATCH THE MARKETING STRATEGY IS NOT APPROPRIATE. SINCE THIS AFFECTS PTS, IT ALSO WOULD SEEM TO ME TO BE RECKLESS AND IRRESPONSIBLE. IN MY 3 YRS OF EXPERIENCE WITH THE CEREC SYSTEM, I HAVE LEARNED TO BE VERY SKEPTICAL OF ALL OF THE CORPS INVOLVED WITH THE TECHNOLOGY AND THEIR GLIB CLAIMS. HAVING LITTLE HOPE RECEIVING AN ANSWER BASED ON SCIENTIFIC EVIDENCE, I AM ASKING YOU TO LOOK INTO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM * NSP 3M * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *