BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRAUMANN EMDOGAIN

    MDR report key: 2823748 · Received October 25, 2012

    Report

    Report Number
    1222315-2012-00017
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    July 6, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BIORA AB
    Product Code
    NQA
    PMA / PMN Number
    P9300021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE AND LOT NUMBER OF THE EMDOGAIN WAS NOT REPORTED BY THE CLINICIAN TO STRAUMANN. HOWEVER, ADDITIONAL INFO RECEIVED ON (B)(6) 2012 FROM THE CLINICIAN STATES THAT THE OP TOOK PLACE ON (B)(6) 2012. (B)(4). THE REVIEW OF THE COMPLAINTS DATABASE CONFIRMED THAT WE HAVE NOT RECEIVED ANY FURTHER SIMILAR COMPLAINTS WITH THIS LOT NUMBER. THE MFR RECEIVED MFR REVIEWED MFG BATCH RECORDS AND CONFIRMS THAT THE PRODUCT WAS RELEASE ACCORDING TO SPECIFICATION. A PREVIOUS EVALUATION BY AN ALLERGIST STATUS THAT THE ALLERGY POTENTIAL OF EMDOGAIN IS VERY LOW.

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT HE USED EMDOGAIN IN THE TREATMENT OF A CLASS 2 FACIAL FURCATION IN SITE 19 ON (B)(6) 2012. HE DEBRIDED THE SITE, USED PREFGEL AND THEN EMDOGAIN. NORMAL POST-OP. TWO WEEKS LATER THE PT PRESENTED WITH MODERATE PAIN IN SITE. THE SITE WAS EROSIVE WITH DRAMATIC ERYTHEMA AND EDEMA. CLINICIAN REPORTS THAT THE GENERAL OBSERVATION ON WOUND HEALING WAS THAT IT WAS IRRITATED AND INFLAMED. HEALING REMARKABLY SLOW WITH SIGNIFICANT SLOUGH OF ATTACHED TISSUE. APPEARS TO BE LOCALIZED ALLERGIC REACTION. THE FLAP WAS NOT TOO THIN NOR WAS THE VASCULATURE COMPROMISED. A FURTHER SURGERY IS NECESSARY TO CORRECT THE SOFT TISSUE RESULT DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAUMANN EMDOGAIN BIOLOGIC MATERIAL, DENTAL NQA BIORA AB CR333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PREFGEL| TETRACYCLINE