BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3022025 · Received March 26, 2013

    Report

    Report Number
    2024312-2013-00068
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE RETURNED. IT WAS VERIFIED THAT LOT NUMBERS 4720558 AND 4704804 ARE RECALL PRODUCTS. A GEL SET TIME TEST OF THE RETURNED PRODUCT FOR LOT NUMBER 4772304 WAS EVALUATED YEILDING WITHIN SPECIFICATIONS. A DHR REVIEWED REVIEW THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE LOSS OF THE RESTORATIONS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4720558, 4704804 AND 4772304. THE PATIENT HAD EXPERIENCED THE LOSS OF A CROWN LESS THAN TWO (2) AFTER PLACEMENT. A NEW CROWN WAS MADE. ON (B)(6) 2013, THE CROWN WAS CEMENTED, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED. A GEL SET TIME TEST OF THE RETAINED SAMPLE FOR LOT 4772304 WAS EVALUATED; YIELDING WITHIN SPECIFICATIONS. IN ADDITION, THERE WAS NO SIMILAR COMPLAINTS WITH THIS LOT. THE LOT NUMBERS 4720558, 4772304 AND 4772304 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS OF MAXCEM ELITE, WHICH WERE ALLEGED TO HAVE BEEN ASSOCIATED WITH THE LOSS OF RESTORATIONS IN THREE (3) PATIENTS; HOWEVER, THE DOCTOR WAS NOT DEFINITIVE AS TO THE NUMBER OF PATIENTS AFFECTED WITH REGARD TO EACH LOT. THIS IS THE THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123353 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R