BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS IMPLANTS

    MDR report key: 8746285 · Received June 28, 2019

    Report

    Report Number
    1060818-2019-00006
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BIOHORIZONS, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 3462 ADVERSE EVENT FILES ARE BEING SUMMARIZED FOR THE 2ND QUARTER 2019 SUBMISSION REPORT. ALL ITEMS LISTED ARE CLASSIFIED AS DZE. NO REMEDIAL ACTION HAS TAKEN PLACE OR REQUIRED. THE OVERALL AVERAGE RESULT OF THE INVESTIGATIONS IS USE ERROR. 6 OF 3462 WERE NOT MANUFACTURED BY THE REPORTING FIRM. 8 OF 3462 WERE RETURNED FRACTURED OR BROKEN. 127 OF 3462 DID NOT HAVE PRODUCT RETURNED FOR INVESTIGATIONS. 2057 OF 3462 ARE UNDER INVESTIGATION. ROW LABELS: TYPES OF IMPLANTS THAT INVOLVED A TOTAL OF 2488 ADVERSE EVENTS: IMPLANT INDICATORS, QTY: EXTERNAL, 62. IMPLANTS, 225. TAPERED PRO, 122. IMPLANTS, 9. SINGLE STAGE, 183. IMPLANTS, 1. TIM, 31. TAPERED INTERNAL, 953. TAPERED INTERNAL - MOUNTLESS, 769. TAPERED INTERNAL PLUS, 601. TAPERED INTERNAL, 179. LASER - LOK 3.0, 10. TAPERED INTERNAL - MOUNTLESS, 301. TAPERED PLATFORM SWITCH, 25. TAPERED SHORT, 61. TAPERED TISSUE LEVEL, 48.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES THE 2ND QUARTER 2019 REPORT FOR A TOTAL OF 3462 EVENTS BEING SUMMARIZED FOR EACH TYPE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537200 BIOHORIZONS IMPLANTS TAPERED OR EXTERNAL IMPLANT DZE BIOHORIZONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1