BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFGEL 0.6ML, 5-PACK

    MDR report key: 7722865 · Received July 26, 2018

    Report

    Report Number
    1222315-2018-00416
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 26, 2018
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    KJJ
    PMA / PMN Number
    K063812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE COMPLAINT DATABASE DETERMINED THAT NO OTHER COMPLAINTS WERE REGISTERED REPORTING SIMILAR MIX-UP ISSUES. THE COMPLAINT IS INPUT TO THE POST MARKET SURVEILLANCE PROCESS AT STRAUMANN WHICH TRACKS AND TRENDS COMPLAINTS WHICH IS EVALUATED WITHIN THE REGULAR PMS REPORT. IF TRENDS ARE IDENTIFIED DURING THIS PROCESS, THEN THIS WILL BE AN INPUT TO CAPA TO DEFINE ANY NECESSARY ADDITIONAL ACTIONS.

    Description of Event or Problem · 1

    THE CLINICIAN PLANNED A PERIODONTAL SURGERY TO TREAT AN INTRAOSSEOUS / FURCATION DEFECT IN SITE #16 IN A (B)(6) MALE PATIENT ON THE TREATMENT PLAN IS TO APPLY PREFGEL (EDTA) TO THE ROOT SURFACE AND LEAVE IT FOR TWO MINUTES TO CONDITION THE SURFACE. THE INTENDED USE OF PREFGEL IS FOR TOPICAL APPLICATION ONTO EXPOSED ROOT SURFACES DURING PERIODONTAL SURGERY IN ORDER TO REMOVE THE SMEAR LAYER. AFTER RINSING THE PREFGEL FROM THE SURGICAL AREA, STRAUMANN EMDOGAIN IS APPLIED. THE INTENDED USE OF EMDOGAIN IS FOR TOPICAL APPLICATION IN CONJUNCTION WITH PERIODONTAL SURGERY TO PROVIDE FOR REGENERATION OF TOOTH SUPPORT LOST TO PERIODONTAL DISEASE OR TRAUMA. THE EMDOGAIN REMAINS IN SITU. DURING THE PLANNED SURGERY ON (B)(6) THE CLINICIAN CONFUSED PREFGEL WITH EMDOGAIN . THIS MEANS THAT THE CLINICIAN APPLIED THE 075.203W PREFGEL 0.6 ML LOT MP183 INTO THE NON-BLEEDING AUGMENTATION SITE AND LEFT IT IN THE DEFECT IN THE PATIENT FOR 72 HOURS. THE CLINICIAN RECALLED THE PATIENT FOR A FOLLOW-UP TREATMENT ON (B)(6) TO CLEAN AND WASH THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564140 PREFGEL 0.6ML, 5-PACK ROOT SURFACE CONDITIONER KJJ INSTITUT STRAUMANN AG NA MP183

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention EMDOGAIN 0.15