BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3727743 · Received April 4, 2014

    Report

    Report Number
    2024312-2014-00204
    Event Type
    Injury
    Date Received
    April 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K101423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS OF OPTIBOND XTR PRIMER AND THREE DIFFERENT LOTS OF OPTIBOND XTR ADHESIVE PRODUCTS ASSOCIATED WITH THE LOSS OF RESTORATIONS, THE DOCTOR COULD NOT VERIFY WHICH PRODUCT OR WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDED ADHESIVE (CATALOG #35108) FROM LOT NUMBERS 4989266, 4657225, AND 4963034 AND PRIMER (CATALOG #35107) FROM LOT NUMBERS 4682091, 4925697, AND 4674873. THE PATIENT HAD RETURNED TO THE DOCTOR'S OFFICE WITH THE CROWN. THE DOCTOR CLEANED OUT THE CROWN AND RE-CEMENTED IT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED; THEREFORE, AN EVALUATION WAS PERFORMED ON A RETAINED SAMPLE FOR EACH OF THE ALLEGED LOTS, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FIFTEEN (15) PATIENTS HAD EXPERIENCED THE LOSS OF A RESTORATION AFTER PLACEMENT WITH THE OPTIBOND XTR AND NX3 PRODUCTS. THIS IS THE FIRST OF FIFTEEN (15) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204049 OPTIBOND XTR RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NX3 CEMENT