BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3812302 · Received May 15, 2014

    Report

    Report Number
    2016150-2014-00128
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    KIF
    PMA / PMN Number
    K102163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE OFFICE ON (B)(4) 2014 TO OBTAIN FURTHER INCIDENT INFORMATION; HOWEVER, THE OFFICE HAS REMAINED UNRESPONSIVE. THE DOCTOR HAD E-MAILED A RESPONSE TO SYBRONENDO CORPORATION ON (B)(6) 2014 ; HOWEVER, NO PATIENT OR INCIDENT INFORMATION WAS REPORTED. DESPITE FURTHER FOLLOW-UPS, NO INCIDENT INFORMATION HAS BEEN RECEIVED. AN UPDATE WILL BE PROVIDED IF ANY FURTHER INFORMATION REGARDING THE ALLEGED INCIDENTS IS OBTAINED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENTS WAS NOT RETURNED AND NO LOT NUMBER OR CATALOG NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT SEVENTY-FIVE (75) PATIENTS HAD EXPERIENCED THE FAILURE AND RE-TREATMENT OF A ROOT CANAL DUE TO THE REALSEAL MATERIAL. THIS IS THE TWENTY-FIFTH OF SEVENTY-FIVE (75) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291935 REALSEAL RESIN, ROOT CANAL FILLING KIF SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R