BEUDAMED
    FDA Adverse Event Summary report: N

    3D-DIRECT

    MDR report key: 1751056 · Received October 19, 2009

    Report

    Report Number
    9681210-2009-00001
    Date Received
    October 19, 2009
    Date of Event
    March 31, 2008
    Report Date
    September 18, 2009
    Manufacturer
    S & C POLYMER GMBH
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAD THE SUSPECT MEDICAL DEVICE USED AS A CLASS V RESTORATION ON TEETH NUMBER 6, 11 AND 10 AND AS AN ENDODONTIC LINGUAL CUSPAL SEAL. THE CLASS V RESTORATIONS WERE IN PLACE FROM 5 1/2 MONTHS TO 7 1/2 MONTHS BEFORE THE START OF THE PT'S SYMPTOMS. THE ENDODONTIC USE WAS PERFORMED APPROX 2 WEEKS AFTER THE START OF THE PT'S SYMPTOMS. PT'S KNOWN ALLERGENS ARE NOT CONTAINED IN THE FORMULA OR USED IN THE MANUFACTURE OF THE SUSPECT DEVICE. WE DO NOT BELIEVE THE SUSPECT MEDICAL DEVICE HAS CAUSED THE PTS SYMPTOMS; HOWEVER, BECAUSE THE ALLERGENS HAVE NOT BEEN DEFINITIVELY LINKED TO PT'S SYMPTOMS, THIS EVENT IS REPORTABLE.

    Description of Event or Problem · 1

    PT REPORTED HAVING RED BUMPS ON THE CROWN OF HER HEAD AND SWELLING OF HER EYES, FACE, LIPS, AND TONGUE DURING AN OFFICE VISIT APPROX ONE YEAR INTO TREATMENT FOR ENTIRE MOUTH (TEETH) RECONSTRUCTION WHICH INCLUDED THE USE OF THE SUSPECT DEVICE ON THE FOLLOWING DATES: (B)(6) 2007 & (B)(6) 2008. PT REPORTED RASH ON HER BODY ON RETURN VISIT OF (B)(6) 2009, ALONG WITH A CONTINUATION OF THE PREVIOUS SYMPTOMS WHICH APPEAR APPROX EVERY OTHER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D-DIRECT TOOTH-COLORED DENTAL COMPOSITE EBF S & C POLYMER GMBH 1M2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other POLYVINYL SILOXIDE IMPRESSION MATERIAL| HIGH NOBEL METALS WERE ALL USED THROUGHOUT THE| 3M LUTING CEMENT| ZILOCANE AND,| CEPTOCANE BEFORE DENTAL WORK.| TEMP-BOND CEMENTING AGENT| DENTAL PORCELAIN| VALIUM| OF A YEAR.| TYLENOL AND| ADVIL POST DENTAL WORK.| RELY-X CEMENTING AGENT| VARIOUS TREATMENTS THAT TOOK PLACE OVER THE COURSE