BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POINT 4 COMPOSITE

    MDR report key: 2950390 · Received February 8, 2013

    Report

    Report Number
    2024312-2013-00043
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 31, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST OCCASION THE RESTORATION HAD CHIPPED OCCURRED APPROXIMATELY TWO (2) WEEKS AFTER PLACEMENT. THE PATIENT RETURNED TO THE OFFICE AND THE DOCTOR REMOVED THE RESTORATION COMPLETELY; HE REPLACED IT AGAIN USING POINT 4 PRODUCT. THE SECOND OCCASION THE RESTORATION HAD CHIPPED OCCURRED APPROXIMATELY ANOTHER TWO (2) WEEKS LATER, AND THE DOCTOR NOTED THAT THE CHIP HAD OCCURRED IN THE MIDDLE OF THE RESTORATION. THE DOCTOR REMOVED THE FULL RESTORATION A SECOND TIME AND REPLACED IT USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED THE CHIPPING OF THEIR RESTORATION FROM TOOTH #21 ON TWO (2) SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53995 POINT 4 COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R