BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS IMPLANTS

    MDR report key: 8746291 · Received June 28, 2019

    Report

    Report Number
    1060818-2019-00005
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    April 30, 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 2488 ADVERSE EVENT FILES ARE BEING SUMMARIZED FOR THE 1ST 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. THIS INFORMATION IS FOR EXEMPTION NUMBER 2006009. 13 OF 2488 WERE NOT MANUFACTURED BY THE REPORTING FIRM. 11 OF 2488 WERE RETURNED FRACTURED OR BROKEN. 184 OF 2488 DID NOT HAVE PRODUCT RETURNED FOR INVESTIGATIONS. ROW LABELS: TYPES OF IMPLANTS THAT INVOLVED THE A TOTAL OF 2488 ADVERSE EVENTS: EXTERNAL, 21. IMPLANT, 20. INTERNAL IMPLANTS, 52. INTERNAL IMPLANTS - FULL LASER LOK, 1. LASER-LOK 3.0, 1. LASER-LOK 3.1, 2. LASER-LOK 3.2, 1. TAPERED IM, 6. TAPERED IMPLANT MOUNTLESS, 7. TAPERED INTERNAL LASER LOK, 6. TAPERED INTERNAL RBT + LASER LOK, 62. TAPERED INTERNAL MOUNTLESS, 46. TAPERED INTERNAL PLUS, 29. TAPERED INTERNAL RBT, 13. TAPERED INTERNAL RBT - MOUNT FREE, 60. TAPERED PLATFORM SWITCH IMPLANT, 13. TAPERED SHORT, 5. TAPERED TISSUE LEVEL, 9.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES THE 1ST QUARTER 2019 ASR REPORT FOR A TOTAL OF 2488 EVENTS BEING SUMMARIZED FOR EACH TYPE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537417 BIOHORIZONS IMPLANTS TAPERED OR EXTERNAL IMPLANT DZE BIOHORIZONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1