BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3996268 · Received August 8, 2014

    Report

    Report Number
    2024312-2014-00552
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 14, 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 PATIENT RETURNED TO THE OFFICE AND A NEW RESTORATION WAS CEMENTED. TO DATE, THE PATIENT IS DOING FINE. THE OPTIBOND XTR PRODUCT (ADHESIVE (CATALOG #35108, LOT #5093730) AND PRIMER (CATALOG #35107, LOT #5093728)) PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A RETAINED SAMPLE WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF A RESTORATION ONE (1) DAY AFTER PLACEMENT USING THE OPTIBOND XTR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470403 OPTIBOND XTR RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R