BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3061626 · Received April 16, 2013

    Report

    Report Number
    2024312-2013-00150
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K101423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN 'ADHESIVE STRENGTH' TEST OF THE RETURNED PRODUCT WAS PERFORMED, 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

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT SHADES WITH THE BONDING FAILURES, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT. THEREFORE, NO LOT NUMBERS WERE IDENTIFIED. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDED LOT NUMBERS 4651948 AND LOT 4674870. PATIENT SPECIFICS WITH REGARD AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR REPORTED THAT THE PATIENT WALKED IN WITH THEIR FILLING IN THEIR HANDS; HE RE-DID THE RESTORATION FOR THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, AN ADHESIVE STRENGTH TEST OF THE RETAIN SAMPLES WERE EVALUATED YIELDING WITHIN IN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED IN REGARDS TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT TWELVE (12) PATIENTS HAD EXPERIENCED BONDING FAILURES AFTER PLACEMENT WITH OPTIBOND XTR. THIS IS THE THIRD OF TWELVE (12) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162881 OPTIBOND XTR RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R