BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNADO BIOACTIVE BONE GRAFT MATRIX

    MDR report key: 22205158 · Received June 13, 2025

    Report

    Report Number
    2249852-2025-00012
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    March 29, 2022
    Report Date
    June 13, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    MQV
    PMA / PMN Number
    K182074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION SITE. LIMITED INFORMATION PROVIDED. POSTEROLATERAL SPINAL SURGERY PERFORMED ON PATIENT ON (B)(6) 2021 IN VERTEBRAE LOCATION L4/L5. TORNADO BIOACTIVE BONE GRAFT MATRIX USED ON PATIENT DURING INITIAL SURGERY. BONE MARROW ASPIRATE, AUTOGRAFT, SPINEWAVE CAPSURE AND LEVA (NOT COLLAGEN MATRIX, INC. PRODUCTS) WERE ALSO USED WITH THE TORNADO BONE GRAFT PRODUCT DURING THE INITIAL PROCEDURE. CLINICIAN CONFIRMED THERE WERE NO COMPLICATIONS DURING INITIAL IMPLANTATION, NO OTHER CONCOMITANT MEDICAL TREATMENT PERFORMED, AND THE DEVICE HANDLED AND PERFORMED EXCELLENT. AT THE SCHEDULED 12-MONTH FOLLOW-UP VISIT ON (B)(6) 2022, X-RAY REVEALED CAGE FRACTURE AND COLLAPSE. CLINICIAN CLASSIFIED THIS AS AN UNEXPECTED ADVERSE EVENT, HOWEVER NO INTERVENTION REQUIRED. IT WAS NOT SPECIFIED WHY X-RAY IMAGING WAS CONDUCTED AT THE FOLLOW-UP APPOINTMENT. NO FURTHER INFORMATION SURROUNDING PATIENT STATUS, PATIENT OUTCOME, OR THE EVENT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636763 TORNADO BIOACTIVE BONE GRAFT MATRIX MINERAL COLLAGEN COMPOSITE BIOACTIVE MQV COLLAGEN MATRIX, INC. 11-5800 MCCBASAN20F1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other