BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOHORIZONS TAPERED SHORT IMPLANTS

    MDR report key: 20599745 · Received November 1, 2024

    Report

    Report Number
    MW5162115
    Event Type
    Other
    Date Received
    November 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEM, INC.
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PRIMARY STABILITY NOT ACHIEVED. 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
    1428784 BIOHORIZONS TAPERED SHORT IMPLANTS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEM, INC. TSC5806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female