BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 3624613 · Received February 12, 2014

    Report

    Report Number
    2024312-2014-00097
    Event Type
    Injury
    Date Received
    February 12, 2014
    Report Date
    February 3, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K082671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS INVOLVED IN THE ALLEGED INCIDENTS WERE NOT RETURNED; THEREFORE, A PHYSICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE FOR EACH OF THE LOTS, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO ANY OF THESE LOTS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED FOURTEEN (14) DIFFERENT LOTS ASSOCIATED WITH NOT CURING, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE 4586772, 4594223, 4862345, 4916637, 4982755, 4996028, 4950206, 4960403, 4201571, 4568733, 4211007, 4397297, 3694407, AND 4665691. PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. THE CURED AND UNCURED COMPOSITE WAS DRILLED OUT AND REPLACED USING A NEW HERCULITE ULTRA TIP DURING THE SAME OFFICE VISIT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT HAS NOT BEEN RETURNED. AN EVALUATION OF RETAINED SAMPLES IS ANTICIPATED, BUT HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE HERCULITE ULTRA COMPOSITE DID NOT POLYMERIZE DURING PROCEDURES ON APPROXIMATELY TWENTY (20) PATIENTS. THIS IS THE ELEVENTH OF TWENTY (20) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91686 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other XT BOND| FLOW-IT