BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 17030777 · Received May 30, 2023

    Report

    Report Number
    MW5117984
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 25, 2023
    Manufacturer
    BIOMET 3I, LLC
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN 2013 I HAD A DENTAL IMPLANT PLACED ON TOOTH #19. AROUND 2 YEARS AGO, THE CROWN BECAME LOOSE. I IMMEDIATELY WENT TO DENTIST-CROWN WAS REMOVED AND SCREW WAS TIGHTENED. THIS HAPPENED SEVERAL TIMES OVER THE COURSE OF TWO YEARS-EACH TIME GOING TO DENTIST. THE SCREW WAS EVENTUALLY REPLACED. AROUND THE END OF (B)(6) 2023, I STARTED TO HAVE LOWER JAW PAIN. I WENT TO THE DENTIST ON (B)(6) 2023. THE DENTIST REMOVED CROWN AND TOOK XRAY. THE XRAY SHOWED THAT THE POST WAS BROKEN. I WAS SENT TO THE SAME ORAL SURGEON WHO DID THE ORIGINAL IMPLANT SURGERY. I WAS INFORMED DEVICE WOULD HAVE TO BE REMOVED AND NO WAY TO SAVE IT. THE FAULTY DEVICE WAS REMOVED (B)(6) 2023. THE REMOVAL WAS DUE TO EQUIPMENT FAILURE AND NOT GUM DISEASE OR OTHER DENTAL ISSUES. THE REMOVAL OF THE IMPLANT WAS QUITE DIFFERENT THAN THE PLACING OF THE DEVICE. THE BONE HAD FUSED WELL WITH THE IMPLANT. THE SURGEON HAD TO DRILL AROUND THE IMPLANT TO REMOVE FROM THE BONE. THIS ALSO REQUIRED A BONE GRAFT. I HAVE BEEN INFORMED THAT THE REMOVAL OF AN IMPLANT DUE TO EQUIPMENT FAILURE IS QUITE RARE. THIS DEVICE WAS FROM IMPLANT DIRECT. IMPLANT TYPE-LEGACY 3. IMPLANT SIZE 3.7X11.5 REF #853711. REFERENCE REPORT: MW5117983, MW5117985, MW5117986 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018206 DENTAL IMPLANT ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP BIOMET 3I, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other