BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTCO-K POST

    MDR report key: 1911388 · Received November 24, 2010

    Report

    Report Number
    8031010-2010-00143
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    ELR
    Removal / Correction Number
    8031010 3/12/09 001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH DENTSPLY HAS NOT RECEIVED ANY REPORTS OF SERIOUS INJURY RESULTING FROM THIS MALFUNCTION, THERE IS A RISK ASSOCIATED WITH RETREATMENT WHERE REMOVAL OF THE POST IS REQUIRED. POSTS ARE TYPICALLY REMOVED USING ULTRASOUND-BASED EXTRACTION TECHNIQUES, THOUGH CLOCKWISE TORQUE CAN ALSO BE USED TO FACILITATE REMOVAL. IN THE LATTER CASE, DAMAGE TO THE REMAINING TOOTH STRUCTURE MAY OCCUR, REQUIRING EXTRACTION OR OTHER INTERVENTION. BECAUSE OF THESE RISKS, DENTSPLY DECIDED TO RECALL THE AFFECTED PRODUCT. CONSEQUENTLY, THE LIKELIHOOD THAT THIS MALFUNCTION WOULD RESULT IN A SERIOUS INJURY IF IT RECURRED HAS BEEN ESTABLISHED. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT CYTCO POSTS CONTAINED A "DESIGN FLAW". THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTCO-K POST ELR DENTSPLY MAILLEFER 392052

    Patients

    Seq Age Sex Outcome Treatment
    1