BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    BIOHORIZONS DENTAL IMPLANT

    MDR report key: 16775795 · Received April 20, 2023

    Report

    Report Number
    1060818-2023-04133
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 21, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION IS BEING FILED TO REDUCE THE TOTAL FROM 12 TO 1. INDIVIDUAL REPORT NUMBERS 1060818-2023-04134,1060818-2023-04135,1060818-2023-04136,1060818-2023-04137,1060818-2023-04138,1060818-2023-04139,1060818-2023-04140,1060818-2023-04141,1060818-2023-04142, 1060818-2023-04143, 1060818-2023-04144, AND 1060818-2023-04145 ARE THE NEW INDIVIDUAL REPORTS ASSOCIATED.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206758 BIOHORIZONS DENTAL IMPLANT DENTAL IMPLANT DZE BIOHORIZONS IMPLANT SYSTEMS IMPLANT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention