BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M ESPE FILETEK SUPREME PLUS FLOWABLE RESTOR

    MDR report key: 1881702 · Received October 20, 2010

    Report

    Report Number
    2110898-2010-00118
    Event Type
    Other
    Date Received
    October 20, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    EBF
    PMA / PMN Number
    K991961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS, RESULTS AND CONCLUSIONS: A RETAIN SAMPLE FROM THE SAME LOT OF MATERIAL WAS TESTED FOR CURING PERFORMANCE USING ISO DEPTH OF CURE TEST METHOD AND WAS FOUND TO BE WITHIN SPEC FOR CURE PERFORMANCE AND PERFORMS PER DESIGN. THE REPORTED EFFECTS ARE NOT EXPECTED FOR THE SUBJECT PRODUCTS; ALL HAVE A FAVORABLE CLINICAL USAGE HISTORY, WITH NO OTHER SIMILAR CASES REPORTED TO 3M (B)(4). THE PLACEMENT AND CURING TECHNIQUES REPORTED BY THE DENTIST ARE NOT CONSISTENT WITH THE 3M (B)(4) INSTRUCTIONS FOR USE. IN ADDITION, THE LOT OF FILETEK SUPREME PLUS UNIVERSAL RESTORATIVE USED IN THIS CASE WAS 1 YEAR PAST ITS STATED SHELF LIFE. IT IS UNK WHAT ROLE THE DENTIST'S TECHNIQUE AND/OR THE USE OF EXPIRED PRODUCT PLAYED IN THE CASE.

    Description of Event or Problem · 1

    SEVERAL PTS (EXACT NUMBER AND INDIVIDUAL DETAILS NOT PROVIDED TO 3M (B)(4)) EXPERIENCED CRACKS IN THEIR TOOTH STRUCTURE (BOTH LINGUAL AND BUCCAL AREAS) AFTER DENTIST PERFORMED POSTERIOR RESTORATIONS WITH 3M (B)(4) FILETEK SUPREME PLUS FLOWABLE RESTORATIVE, 3M (B)(4) FILETEK SUPREME PLUS UNIVERSAL RESTORATIVE, AND 3M (B)(4) ADPER SINGLE BOND PLUS ADHESIVE. RESTORATIONS WERE EITHER NEW, OR WERE DONE TO REPLACE OLD AMALGAM FILLINGS. SOME PTS HAVE REQUIRED CROWNS OR ROOT CANALS; ALL PTS ARE REPORTED TO BE FINE. DENTIST INDICATED HER TECHNIQUE TO BE AS FOLLOWS: PLACES ABOUT 1 MM OF FILETEK SUPREME PLUS FLOWABLE RESTORATIVE IN BOX AND LIGHT CURES; APPLIES 2 TO 3 COATS OF ADPER SINGLE BOND PLUS ADHESIVE AND LIGHTLY AIR DRIES BETWEEN EACH LAYER AND LIGHT CURES; PLACES FILETEK SUPREME PLUS UNIVERSAL RESTORATIVE GREATER OR LESS THAN 2 MM IN INCREMENTAL DEPTH AND LIGHT CURES FOR 30 SECONDS. DENTIST ALSO INDICATED SHE USES A SLEEVE OVER THE LIGHT GUIDE AND TIP OF THE CURING LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ESPE FILETEK SUPREME PLUS FLOWABLE RESTOR MATERIAL, TOOTH SHADE, RESIN EBF 3M ESPE DENTAL PRODUCTS NA 9JR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention