BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILE

    MDR report key: 2022791 · Received March 17, 2011

    Report

    Report Number
    2024312-2011-00059
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K052106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE RETAIN SAMPLES FROM THE SAME LOT WERE EVALUATED FOR ADHESIVE STRENGTH AND MET PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES DURING THE PRODUCTION PROCESS. IN ADDITION, A REVIEW OF COMPLAINT DATABASE TRENDING INDICATED THAT NO SIMILAR COMPLAINTS WERE RECEIVED. IN A FOLLOW-UP CONVERSATION ON (B)(6), 2011, THE DOCTOR MENTIONED THAT THE BOND-IT LIGHT CURE ADHESIVE HE USED IN THE INCIDENT EXPIRED IN AUGUST 2007. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THE DEBONDS WERE NOT THE RESULT OF A PRODUCT FAILURE AND WERE LIKELY DUE TO A USER-RELATED PROBLEM IN THAT THE DOCTOR USED EXPIRED PRODUCT. THE PATIENT IS FINE AND THE RESTORATION WAS REDONE WITH SIMILE WITHOUT FURTHER INCIDENT. (B)(4). TESTED RETAIN SAMPLE FROM SAME LOT.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR REPORTED THAT FOUR PATIENTS EXPERIENCED FAILED RESTORATIONS THAT HAD BEEN PLACED WITH SIMILE COMPOSITE. IN THIS INCIDENT, A RESTORATION PLACED WITH SIMILE ON A LOWER MOLAR CHIPPED WITHIN SEVERAL MONTHS AFTER PLACEMENT. THIS MDR IS THE SECOND OF FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMILE MATERIAL, TOOTH SHADE RESIN EBF PENTRON CLINICAL 3387439

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOND-IT PRIMER| BOND-IT LIGHT CURE ADHESIVE