BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMDOGAIN, COURSE

    MDR report key: 23247146 · Received October 8, 2025

    Report

    Report Number
    0009613348-2025-015299
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 8, 2025
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    NQA
    PMA / PMN Number
    NOT MEDICA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE (B)(6) 2025, STRAUMANN WAS NOTIFIED OF A CUSTOMER COMPLAINT ABOUT A DOCTOR USING 440.230V10 EMDOGAIN COURSE MATERIAL BATCH EPZM8 IN A PATIENT. INVESTIGATION OF ARTICLE 440.230V10 EMDOGAIN COURSE MATERIAL BATCH NR EPZM8 CONFIRMED THAT THE PRODUCT IS CORRECTLY LABELED AS COURSE MATERIAL AND ¿NOT FOR HUMAN USE¿. THIS IS ALSO CONFIRMED BY THE PHOTOS PROVIDED BY THE CUSTOMER. EMDOGAIN COURSE MATERIAL IS TO BE USED FOR EDUCATION PURPOSES ONLY. IT IS INTENDED TO BE SOLD TO DESIGNATED TRAINING AND EDUCATION PROVIDERS UNDER THE CONTROL OF THE RESPECTIVE TE TEAMS WORLDWIDE. COURSE MATERIALS ARE NOT SUBJECT TO THE SAME LEVEL OF CONTROLS AND ANALYSIS DURING PRODUCTION, THEREFORE EMDOGAIN COURSE MATERIAL MAY NOT FULFIL THE SPECIFICATIONS AND REQUIREMENTS OF THE COMMERCIAL EMDOGAIN PRODUCT. THE STERILITY OF THE SYRINGE AND ITS CONTENT CANNOT BE GUARANTEED. TO DATE, WE HAVE RECEIVED ONE (1) SINGLE CUSTOMER COMPLAINT ABOUT THE USE OF EMDOGAIN COURSE MATERIAL IN A PATIENT IN THE USA, AND NO ADVERSE EVENT WAS REPORTED FOR THIS CASE. WHILE CONSIDERED UNLIKELY, BECAUSE THE STERILITY OF THE SYRINGE AND ITS CONTENT CANNOT BE GUARANTEED, RISK OF INFECTION CANNOT BE ENTIRELY EXCLUDED AND NO DEFINITIVE CONCLUSION ABOUT LONG-TERM HEALTH EFFECTS CAN BE MADE. A DETAILED REVIEW OF SALES DATA SHOWED THAT SOME END-CUSTOMERS MAY HAVE INADVERTENTLY BEEN ABLE TO PURCHASE AND RECEIVE COURSE MATERIALS. INSTITUT STRAUMANN HAS DECIDED TO INITIATE A VOLUNTARY FIELD SAFETY CORRECTIVE ACTION TO REMOVE THESE SOLD UNITS FROM THE MARKET TO ENSURE THAT A SIMILAR EVENT CANNOT TAKE PLACE. CAPA-0000107 HAS BEEN OPENED TO COMPLETE PRELIMINARY ROOT CAUSE INVESTIGATION AND IDENTIFY APPROPRIATE CORRECTIVE ACTIONS AS APPLICABLE. PRELIMINARY ROOT CAUSE HAS IDENTIFIED THIS TO BE A HUMAN ERROR WHEREBY THE CUSTOMER SERVICE INADVERTENTLY SOLD COURSE MATERIAL TO A COMMERCIAL CUSTOMER. IN SPITE OF THE APPROPRIATE LABELLING AND IDENTIFICATION AS COURSE MATERIAL, END USER FAILED TO FOLLOW INSTRUCTIONS AND USED THE ITEM ON A PATIENT. FURTHER INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 0

    STRAUMANN WAS INFORMED VIA A CUSTOMER COMPLAINT (ID (B)(6)) ON (B)(6) 2025 THAT A DOCTOR USED 440.230V10 EMDOGAIN COURSE MATERIAL BATCH EPZM8 IN A PATIENT ON (B)(6) 2025. DOCTOR CONFIRMED ON (B)(6) 2025 THAT THERE WERE NO COMPLICATIONS OR ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS PRODUCT ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521516 EMDOGAIN, COURSE EMDOGAIN, COURSE NQA INSTITUT STRAUMANN AG EPZM8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention