BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND FL

    MDR report key: 2080681 · Received May 6, 2011

    Report

    Report Number
    2024312-2011-00126
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K031444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR STATED THAT NEW FILLINGS WERE PLACED WITH A DIFFERENT PRODUCT AND SINCE DOING SO, HAS RECEIVED NO FURTHER COMPLAINTS OF TOOTH SENSITIVITY. THE DOCTOR STATED THAT TWO BOTTLES OF OPTIBOND FL ADHESIVE WERE IN USE AT THE TIME OF THE INCIDENTS; HOWEVER, ONLY ONE LOT COULD BE IDENTIFIED. THE DOCTOR WAS ABLE TO IDENTIFY TWO LOTS OF OPTIBOND FL PRIMER THAT WERE IN USE. THE DOCTOR DID NOT PROVIDE SPECIFICS ON THIS INCIDENT NOR DID SHE IDENTIFY WHICH LOT AND WHICH COMBINATION OF PRODUCTS WERE USED IN EACH INCIDENT. NO PRODUCT WAS RETURNED TO KERR CORPORATION FOR EVALUATION; THEREFORE, RETAIN SAMPLES WERE VISUALLY INSPECTED AND MET SPECIFICATIONS FOR APPEARANCE IN THAT THE MATERIAL WAS HOMOGENEOUS AND FREE OF CONTAMINATION. A REVIEW OF THE MANUFACTURING RECORDS FOR EACH IDENTIFIED LOT INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A REVIEW OF COMPLAINT DATABASE TRENDING FOR EACH LOT SHOWED THAT NO SIMILAR COMPLAINTS WERE RECEIVED. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THE ALLEGED TOOTH SENSITIVITY WAS AN ISOLATED INCIDENT AND WAS NOT THE RESULT OF A PRODUCT FAILURE. TESTED RETAIN SAMPLES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, DOCTOR ALLEGED THAT NINE (9) PATIENTS EXPERIENCED TOOTH SENSITIVITY AFTER FILLINGS WERE PLACED WITH OPTIBOND FL. THE DOCTOR STATED THAT THE SENSITIVITY WAS TREATED BY REMOVING THE FILLINGS AND PLACING NEW ONES. THIS MDR IS THE SECOND OF NINE REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other