BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 4055217 · Received September 3, 2014

    Report

    Report Number
    2024312-2014-00600
    Event Type
    Injury
    Date Received
    September 3, 2014
    Report Date
    August 19, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    MZW
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED TO THE OFFICE AND THE DOCTOR CLEANED OUT AND RE-CEMENTED THE RESTORATION USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. THE DOCTOR REPORTED THAT HE DID NOT USE THE AUTOMIX TIPS PROVIDED IN THE MAXCEM ELITE PACKAGING AS STATED IN THE DIRECTIONS FOR USE. HE WAS AWARE THAT A NEW TIP IS INTENDED TO BE USED FOR EACH PATIENT; HOWEVER, IN AN ATTEMPT TO SAVE ON "WASTED PRODUCT", HE HAD EXTRUDED THE MATERIAL ONTO A MIXING PAD DIRECTLY FROM THE UNCAPPED SYRINGE AND MIXED THE PRODUCT BY HAND. IT HAS BEEN CONCLUDED THAT THE INTENTIONAL FAILURE TO FOLLOW INSTRUCTIONS WAS THE ROOT CAUSE OF THIS INCIDENT. THE DOCTOR WAS INFORMED BY KERR ON PROPER PRODUCT USAGE.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT APPROXIMATELY FIVE (5) PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN AFTER PLACEMENT WITH THE MAXCEM ELITE CLEAR PRODUCT. THIS IS THE FIFTH OF FIVE (5) COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538672 MAXCEM ELITE DENTAL CEMENT MZW KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R