BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    MDR report key: 17529372 · Received August 12, 2023

    Report

    Report Number
    MW5136300
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    April 13, 2022
    Report Date
    May 3, 2022
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    WHY DO YOU BELIEVE THE EVENT OCCURRED? NOT SURE, IMPLANT 8+9 WERE PLACED # 8 FAILED TO INTEGRATE. AT THE TIME OF THE EVENT OR IMPLANT FAILURE/REMOVAL, WAS THERE? (CHECK ALL THAT APPLY) PAIN:YES; MOBILITY: YES. DESCRIPTION OF EVENT: T CUP CROWNS POT ON FIRST, FINAL CROWNS INSTALLED (B)(6) 2022 (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
    2117012 IMPLANT, ENDOSSEOUS, ROOT-FORM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS, INC BTA3810, 1907468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown