BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRUCTUR 3

    MDR report key: 3608286 · Received January 14, 2014

    Report

    Report Number
    8010908-2013-00001
    Event Type
    Other
    Date Received
    January 14, 2014
    Date of Event
    December 10, 2013
    Report Date
    January 13, 2014
    Manufacturer
    VOCO GMBH
    Product Code
    EBG
    PMA / PMN Number
    K040769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT DEFECT WAS FOUND AS A RESULT OF TESTING CARRIED OUT ON THE MATERIAL RETURNED TO US. THE USER'S REPORT DOES NOT CONTAIN ANY INDICATION OF PRODUCT FAILURE EITHER. WE HAVE NEVER RECEIVED INFO ON OTHER INCIDENTS OF THIS TYPE IN RELATION TO STRUCTURE 3. IN SUMMARY OF THE EVALUATION OF INFORMATION RECEIVED ON THIS INCIDENT, THE TESTING RESULTS AND THE ASSESSMENT OF THE HISTORY OF COMPLAINTS REGARDING STRUCTURE 3, WE CONCLUDE THAT THE PT'S COMPLAINTS WERE PRESUMABLY IATROGENICALLY INDUCED. NO CORRECTIVE MEASURES HAVE BEEN SCHEDULED IN CONSEQUENCE OF THIS INCIDENT.

    Description of Event or Problem · 1

    AFTER PLACEMENT OF A TEMPORARY RESTORATION THAT WERE MADE OF STRUCTURE 3, IT CAME TO PAINFUL INFLAMMATION. THE INFLAMMATION HAD OCCURRED IN A TOTAL OF 4 PTS OF DIFFERENT AGES AND GENDER, AND DECAYED AFTER 3-4 DAYS. NO INTERVENTIONS WERE REQUIRED. MORE DETAILED INFO ON THE PTS WERE NOT PROVIDED BY THE DENTIST. IN THE MEANTIME, THE PTS WERE TREATED WITH A DEFINITIVE RESTORATION. THE PTS ARE DOING WELL. THERE ARE NO CONSEQUENCES FOR THE PTS REVEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34653 STRUCTUR 3 CROWN AND BRIDGE, TEMPORARY, RESIN EBG VOCO GMBH 1332545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other