BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND SOLO PLUS

    MDR report key: 1936305 · Received December 22, 2010

    Report

    Report Number
    2024312-2010-00104
    Event Type
    Injury
    Date Received
    December 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K990498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR ALLEGED THAT THERE WERE MULTIPLE BONDING FAILURES WITH THIS PRODUCT, HOWEVER NO FURTHER DETAILS WERE PROVIDED. FIVE ATTEMPTS ((B)(6)) WERE MADE TO CONTACT THE OFFICE IN ORDER TO OBTAIN FURTHER INFORMATION ON THE DE-BONDING INCIDENTS, HOWEVER, NO RESPONSE WAS RECEIVED FROM THE DOCTOR'S OFFICE. THE PRODUCT WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE WITHIN PRODUCT SPECIFICATIONS FOR ADHESIVE STRENGTH. A VISUAL EXAMINATION OF THE PRODUCT INDICATED THAT THE PRODUCT WAS HOMOGENEOUS AND FREE OF CONTAMINATION. NO SIMILAR COMPLAINTS WERE REPORTED REGARDING THIS PRODUCT LOT. IT WAS THEREFORE CONCLUDED THAT THIS WAS AN ISOLATED INCIDENT THAT WAS A RESULT OF A USER OR TECHNIQUE RELATED PROBLEM AND NOT TO A PRODUCT FAILURE. (B)(4)

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED THAT MULTIPLE FILLINGS THAT HAD BEEN PLACED WITH OPTIBOND SOLO PLUS DE-BONDED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIBOND SOLO PLUS RESIN TOOTH BONDING AGENT KLE KERR CORPORATION 3450315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GLUMA