BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUTMENT, IMPLANT DENTAL ENDOSSEOUS

    MDR report key: 19831133 · Received July 24, 2024

    Report

    Report Number
    MW5157613
    Event Type
    Injury
    Date Received
    July 24, 2024
    Report Date
    March 27, 2024
    Manufacturer
    ZIMVIE / BIOMET 3I, LLC
    Product Code
    NHA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INFECTION. IMPLANT AT SITE "#19 WAS HAVING PAIN. HAD PT IN, REMOVED HEALING ABUTMENT AND FOUL ODOR DETECTED. INFECTION AROUND #19. REMOVED IMPLANT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534120 ABUTMENT, IMPLANT DENTAL ENDOSSEOUS ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA ZIMVIE / BIOMET 3I, LLC TSX54B10

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female