BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRUCTUR PREMIUM

    MDR report key: 2645424 · Received June 26, 2012

    Report

    Report Number
    8010908-2012-00001
    Event Type
    Other
    Date Received
    June 26, 2012
    Date of Event
    May 22, 2012
    Report Date
    June 26, 2012
    Manufacturer
    VOCO GMBH
    Product Code
    EBG
    PMA / PMN Number
    K040769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    STRUCTUR PREMIUM IS A COMPOSITE MATERIAL BASED ON A MATRIX CONSISTING OF DIMETHACRYLATES. THESE MAY WELL CAUSE THE DESCRIBED COMPLAINTS IN SENSITIVE PATIENTS. THE STRUCTUR PREMIUM INSTRUCTIONS FOR USE LIST THE POTENTIALLY ALLERGENIC INGREDIENTS. SUCCESSFUL TREATMENT OF AN ALLERGIC REACTION WITH ANDOLEX, HOWEVER, IS NOT NORMALLY TO BE EXPECTED. IT WAS NOT KNOWN AT THE BEGINNING OF TREATMENT WHETHER OR NOT THE PATIENT IS ALLERGIC TO COMPOSITE MATERIALS. THE COMPLAINTS MAY ALSO HAVE BEEN CAUSED BY A REACTION TO THE LUTING CEMENT, ESPECIALLY IN CASE OF EUGENOL-CONTAINING PRODUCTS. LACK OF INFORMATION REGARDING THE LUTING CEMENT USED DOES NOT ALLOW A DEFINITE EVALUATION OF THIS. NO PRODUCT DEFECT WAS FOUND AS A RESULT OF TESTING CARRIED OUT ON THE MATERIAL RETURNED TO US AND ON THE CORRESPONDING RETAINED SAMPLES. THE USER'S REPORT DOES NOT CONTAIN ANY INDICATION OF PRODUCT FAILURE EITHER. WE HAVE NEVER RECEIVED INFORMATION ON OTHER INCIDENTS OF THIS TYPE IN RELATION TO STRUCTUR PREMIUM. IN SUMMARY OF THE EVALUATION OF INFORMATION RECEIVED ON THIS INCIDENT, THE TESTING RESULTS AND THE ASSESSMENT OF THE HISTORY OF COMPLAINTS REGARDING STRUCTUR PREMIUM, WE CONCLUDE THAT THE PATIENT'S COMPLAINTS WERE PROBABLY IATROGENICALLY INDUCED. NO CORRECTIVE MEASURES HAVE BEEN SCHEDULED IN CONSEQUENCE OF THIS INCIDENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012: THE PATIENT WAS FITTED WITH A TEMPORARY CROWN MADE FROM STRUCTUR PREMIUM (TOOTH 25). THE FOLLOWING DAY, A PAINFUL SWELLING OCCURRED ON THE INSIDE OF THE CHEEK ADJACENT TO THE TEMPORARY CROWN. ON (B)(6) 2012: REMOVAL OF THE TEMPORARY CROWN WHICH WAS THEN REPLACED WITH AN ALUMINIUM CAP ATTACHED WITH EITHER TEMPBOND OR NOBITEC. MORE SPECIFIC DETAILS ON THIS WERE NOT COMMUNICATED. TO ABATE SYMPTOMS, THE PATIENT WAS ASKED TO RINSE HER MOUTH WITH ANDOLEX THREE TIMES A DAY AND TO CONTACT HER GP. ANDOLEX IS GIVEN LOCALLY FOR INFLAMMATIONS OF THE MOUTH OR PHARYNX, OR FOR A SORE THROAT. TO OUR KNOWLEDGE, FURTHER MEASURES FOR TREATMENT OF THIS PATIENT WERE NOT REQUIRED. ON (B)(6) 2012: TELEPHONE CONVERSATION BETWEEN THE DENTIST AND THE PATIENT, WHO ADVISED THAT THE SWELLING HAD SUBSIDED BUT THAT SHE EXPERIENCED PAIN WHEN BRUSHING HER TEETH. ON (B)(6) 2012: CHECK-UP APPOINTMENT; SMALL BLISTERS REMAINING IN THE PATIENT'S MOUTH, BUT NO FURTHER PROBLEMS. SWELLING HAS SUBSIDED, PATIENT NO LONGER EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRUCTUR PREMIUM CROWN AND BRIDGE, TEMPORARY, RESIN EBG VOCO GMBH 1149351

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention