BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE

    MDR report key: 17488382 · Received August 9, 2023

    Report

    Report Number
    MW5121081
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    December 20, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BIOMET 3I, LLC
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    NON-INTEGRATION. IMPLANT LOOSE AT SURGICAL RELEASE, REMOVED, GRAFTED SITE. FILE (B)(4). 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
    1684158 OSSEOTITE IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOMET 3I, LLC XIITP6510 2022011128

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown