BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRIALIT-2 SYNCHRO IMPLANT D3.8/L13

    MDR report key: 8257422 · Received January 17, 2019

    Report

    Report Number
    9681851-2018-00020
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    November 7, 2018
    Report Date
    January 17, 2019
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K974358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT CAN BE ASSUMED, THAT DUE TO THE INFECTION A BONE LOSS HAD TAKEN PLACE AHEAD OF THE EVENT. PER ASR EXEMPTION # E1997021, THE OCCURRENCE OF MULTIPLE SERIOUS INJURIES (IMPLANT AND TOOTH LOSS) AS A RESULT OF A SINGLE EVENT OR DEVICE FAILURE ARE NOT COVERED BY THE EXEMPTION AND MUST BE REPORTED AS AN INDIVIDUAL MDR. THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. IMPLANT LOSS USUALLY IS NOT PRODUCT RELATED, BUT A MATTER OF PATIENTS CONDITION, HYGIENE, HABITS, ETC. AND/OR OPERATIONAL CONTEXT, SUCH AS E.G. INADEQUATE PLANNING, PROSTHETIC OVERLOAD, ETC. OPTICAL INVESTIGATION OF THE IMPLANT DOES NOT REVEAL ANY "CONSPICUITIES". NO INDICATION FOR THE IMPLANT TO BE FAULTY. THE IMPLANT WAS ABOUT 11 YEARS UNDER FUNCTIONAL LOADING.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT RECEIVED A FRIALIT SYNCHRO IMPLANT, D3.8/ L13 IN "REGIO" #20 IN (B)(6) 2007, RESTORED WITH AN IMPLANT/ TOOTH SUPPORTED BRIDGE (#18, #19, #20). THE IMPLANT WAS SPLINTED WITH NATURAL TOOTH IN "REGIO" #18, #19 WAS A PONTIC. ON (B)(6) 2018 THE DENTURE WAS REMOVED WITH THE IMPLANT AND THE FRAGMENT OF THE SUPPORTING TOOTH. THERE IS NO X-RAY DOCUMENTATION AVAILABLE. THE PATIENT EXPERIENCED AN INFECTION. NO INFORMATION ABOUT BONE QUALITY OR ORAL HABITS OF THE PATIENT AVAILABLE. THE BRIDGE WAS FOUND LOOSE. IT WAS DISCOVERED THAT THE TOOTH WAS FRACTURED. WHEN REMOVING THE BRIDGE, THE IMPLANT CAME OFF AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48549 FRIALIT-2 SYNCHRO IMPLANT D3.8/L13 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH NA 101866710702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention