BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS TAPERED INTERNAL IMPLANT

    MDR report key: 7474279 · Received April 30, 2018

    Report

    Report Number
    1060818-2018-00027
    Event Type
    Injury
    Date Received
    April 30, 2018
    Report Date
    April 30, 2018
    Manufacturer
    BIOHORIZONS, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONS SUMMARIZED FOR EXEMPTION NUMBER 2006009 RELATED TO 3857 EVENTS FOR THE 1ST QUARTER 2018 ALTERNATIVE SUMMARY REPORT ARE AS FOLLOWS CONCLUDED NO PRODUCT ISSUES OR REMDIAL ACTION REQUIRED. NO SERIOUS INJURIES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES DZE REPORTED EVENTS WHERE 3857 OF EVENTS BEING SUMMARIZED FOR EACH REPRESENTATIVE TYPE OF REPORT, MALFUNCTIONS OR SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317466 BIOHORIZONS TAPERED INTERNAL IMPLANT TAPERED INTERNAL IMPLANT DZE BIOHORIZONS, INC. TLR4610

    Patients

    Seq Age Sex Outcome Treatment
    1