BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M ESPE FILTEK SUPREME PLUS UNIVERSAL RESTO

    MDR report key: 1922908 · Received December 9, 2010

    Report

    Report Number
    2110898-2010-00147
    Event Type
    Other
    Date Received
    December 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    EBF
    PMA / PMN Number
    K010781
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS, RESULTS AND CONCLUSIONS: THE SECOND DEVICE USED IN THIS EVENT WAS NOT RETURNED TO 3M (B)(4) FOR EVALUATION, WHILE A LOT NUMBER WAS PROVIDED, IT HAD EXCEEDED ITS STATED SHELF LIFE BY MORE THAN 1 YEAR. SINCE 3M (B)(4) ONLY MAINTAINS RETAIN SAMPLES FOR 1 YEAR BEYOND THE EXPIRATION DATE, NO RETAIN SAMPLE WAS AVAILABLE FOR TESTING. THIS MANUFACTURER REPORT IS FOR DEVICE 2 OF 3 INVOLVED IN ONE SINGLE ADVERSE EVENT. REFER TO MANUFACTURER REPORT # 2110898-2010-00118 (DEVICE 1) AND #2110898-2010-00148 (DEVICE 3) FOR INFO ON THE OTHER TWO DEVICES. 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 FILTEK SUPREME PLUS UNIVERSAL RESTORATIVE (DEVICE 2) 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) FILTEK SUPREME PLUS FLOWABLE RESTORATIVE, 3M (B)(4) FILTEK 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 1MM OF FILTEK 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 FILTEK SUPREME PLUS UNIVERSAL RESTORATIVE GREATER OR LESS THAN 2MM 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 FILTEK SUPREME PLUS UNIVERSAL RESTO MATERIAL, TOOTH SHADE, RESIN EBF 3M ESPE DENTAL PRODUCTS NA 6FF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention