BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 4219626 · Received November 3, 2014

    Report

    Report Number
    2024312-2014-00650
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 14, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    MZW
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTAL OFFICE CONTACTED KERR TECHNICAL ON 10/14/14 REQUESTING COMPOSITION INFORMATION, AS THE PATIENT HAD RECENTLY BEEN DIAGNOSED WITH AN ALLERGY TO BALSAM OF PERU. THE DENTIST CEMENTED AN IMPLANT CROWN ON (B)(6) 2010 USING THE MAXCEM ELITE CLEAR PRODUCT. THE PATIENT BEGAN TO EXPERIENCE LIP SWELLING AND SOUGHT FURTHER MEDICAL ATTENTION FROM AN ORAL & MAXILLOFACIAL PATHOLOGIST. THE PATHOLOGIST DIAGNOSED THE PATIENT WITH AN ALLERGIC REACTION TO THE IMPLANT, AND THE IMPLANT WAS REMOVED ON (B)(6) 2011. THE SWELLING HAD SUBSIDED SOMEWHAT, BUT DID NOT COMPLETELY RECEDE. THE PATIENT RETURNED TO THE DENTAL OFFICE AND A FIXED BRIDGE WAS CEMENTED ON (B)(6) 2011 USING MAXCEM ELITE CLEAR. ON (B)(6) 2011, THE PATIENT RETURNED TO THE DENTAL OFFICE FOR REMOVAL OF THE BRIDGE BECAUSE THE LIP SWELLING HAD RETURNED. THE PATIENT RETURNED TO THE DENTAL OFFICE ON (B)(6) 2011 AND A NEW BRIDGE MADE FROM A DIFFERENT MATERIAL WAS CEMENTED USING MAXCEM ELITE CLEAR, AND THE DENTIST ALSO ADDED A RETAINER TO KEEP THE BRIDGE FROM TOUCHING THE PATIENT'S LIP. AT THIS TIME, THE PATIENT'S GUM IS INFLAMED AND THE SWELLING OF THE LIP IS STILL PRESENT, ALTHOUGH LESS SEVERE. THE DENTAL OFFICE WAS NOT DEFINITIVE AS TO WHETHER OR NOT THE MAXCEM ELITE WAS RELATED TO THIS INCIDENT. KERR HAS REQUESTED THAT THE CUSTOMER REPORT ANY NEW INFORMATION WITH REGARD TO THIS PATIENT. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED, AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DENTAL OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED A SWOLLEN LIP AND GUM AFTER RESTORATIVE CEMENTATION PROCEDURES WERE COMPLETED USING THE MAXCEM ELITE CLEAR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701016 MAXCEM ELITE CEMENT, DENTAL MZW KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R