BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIV POWDER GP CEMENT

    MDR report key: 2013529 · Received February 3, 2011

    Report

    Report Number
    1032227-2011-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BRASSELER USA
    Product Code
    EMA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FROM CUSTOMER AND WAS EVALUATED BY COMPANY PERSONNEL. THE PRODUCT REFERENCED IN THE COMPLAINT IS PART OF A TWO-PART CEMENT. THE POWDER IS MIXED WITH A LIQUID TO PRODUCE THE CEMENT USED IN ENDODONTIC PROCEDURES TO SEAL TOOTH CANAL TUBULARS AND ACT AS AN ADHERENT FOR THE ROOT CANAL FILLER (I..E. GUTTA PERCHA). THE PRODUCT WAS MIXED WITH THE LIQUID (ALSO RETURNED FROM THE CUSTOMER) AND ALLOWED TO SET UP. WHEN THE PRODUCT WAS MIXED ACCORDING TO DIRECTIONS AS A 'CLUMP' OR 'BALL' (SMALL SURFACE AREA), THE SET UP TIME WAS BETWEEN 11.5 MINUTES AND 45 MINUTES. WHEN THE PRODUCT WAS MIXED ACCORDING TO DIRECTIONS AS A SMEAR (GREATER SURFACE AREA), THE PRODUCT SET UP TIME WAS BETWEEN 11.5 AND 15 MINUTES. INSTRUCTIONS FOR USE INDICATE THE PRODUCT HAS A WORKING TIME OF 11.5 MINUTES FROM COMPLETION OF THE MIXING OF COMPONENTS UNTIL THE SEALER IS SET. THIS TIME CAN BE EXTENDED TO 20 MINUTES BY MIXING ON A CHILLED GLASS SLAB. THE REMAINING PRODUCT WAS FORWARDED TO THE THIRD PARTY MANUFACTURER FOR ADDITIONAL INVESTIGATION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE DENTAL OFFICE ADVISED THAT WHEN THE DENTIST USED THE POWDER AND LIQUID, THE SEALER DID NOT SET UP WHEN MIXED. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIV POWDER GP CEMENT EMA BRASSELER USA ACTIV GP 1705145-15B0809

    Patients

    Seq Age Sex Outcome Treatment
    1