BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3582093 · Received January 17, 2014

    Report

    Report Number
    2024312-2014-00029
    Event Type
    Injury
    Date Received
    January 17, 2014
    Report Date
    January 13, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K101423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPTIBOND XTR PRODUCT PRIMER (CATALOG #35106, LOT #4848495) AND ADHESIVE (CATALOG #35108, LOT #4873349) INVOLVED IN THE ALLEGED INCIDENT WAS RECEIVED IN A CONDITION WHERE ANALYSIS WAS IMPOSSIBLE; THEREFORE, AN ADHESIVE STRENGTH TEST OF THE RETAIN SAMPLES WERE EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE, GENDER, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR COULD NOT RECALL SPECIFIC PATIENT OR INCIDENT DETAILS. THE DOCTOR EITHER RE-MADE THE CROWN AND CEMENTED IT OR HE RE-CEMENTED THE CROWN FOR THE PATIENT WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FOUR (4) PATIENTS HAD EXPERIENCED THE LOSS RESTORATIONS WITHIN ONE (1) TO THREE (3) MONTHS AFTER PLACEMENT USING OPTIBOND XTR AND NX3 DUAL CURE PRODUCTS. THIS IS THE FOURTH OF FOUR (4) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44262 OPTIBOND XTR AGENT, TOOTH BONDING RESIN KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NX3 DUAL CURE