BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA SILO TFX SI JOINT FUSION DEVICE

    MDR report key: 24273115 · Received February 5, 2026

    Report

    Report Number
    MW5183434
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 7, 2025
    Report Date
    January 30, 2026
    Manufacturer
    AURORA / AURORA SPINE, INC.
    Product Code
    OUR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AURORA SILO TFX SI JOINT FUSION DEVICE FAILED. THIS FUSION SURGERY TOOK PLACE ON (B)(6) 2025, PERFORMED BY DR. (B)(6) OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335847 AURORA SILO TFX SI JOINT FUSION DEVICE SACROILIAC JOINT FIXATION OUR AURORA / AURORA SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other