BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCORE

    MDR report key: 22162112 · Received June 6, 2025

    Report

    Report Number
    2249852-2025-00013
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    April 15, 2024
    Report Date
    June 6, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    MQV
    UDI-DI
    00813954024776
    PMA / PMN Number
    K182074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS FOR SUSPECT DEVICE 1 AND IS THE PARENT MDR. PLEASE REFER TO MDR NUMBER 2249852-2025-00014 FOR THE OTHER REPORTED SUSPECT DEVICE.

    Description of Event or Problem · 0

    COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. PATIENT WAS DIAGNOSED WITH CHRONIC LOWER BACKPAIN. TWO ITEMS OF THE BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE WERE USED ON A PATIENT DURING INITIAL SURGERY ON (B)(6) 2024. PRODUCT WAS IMPLANTED IN PATIENT IN LOCATION L3-4 AND L4-5. A BONE MARROW ASPIRATE AND ALLOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS) WERE USED IN CONJUNCTION WITH THE BIOCORE BIOACTIVE PRODUCT. ADDITIONALLY, IT WAS REPORTED THAT INVICTUS SCREWS AND A CAGE WAS ALSO USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER REPORTED NO COMPLICATIONS WERE NOTED DURING IMPLANT AND THE PRODUCT HANDLED AND PERFORMED EXCELLENT. ON (B)(6) 2024, THERE WAS MILD ANTERIOR SUBSIDENCE OF THE L4-L5 CAGE INTO THE ANTERIOR L5 VERTEBRAL BODY. CUSTOMER CONFIRMED THIS WAS NOT A SERIOUS ADVERSE EVENT AND REPORTED PHYSICAL THERAPY AS THE BEHAVIORAL/LIFESTYLE INTERVENTION FOR THE PATIENT. CUSTOMER STATED PATIENT WAS TO START PHYSICAL THERAPY ON (B)(6) 2024. NO FURTHER DETAILS SURROUNDING OUTCOME OF PHYSICAL THERAPY, PATIENT STATUS, AND PATIENT OUTCOME WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480025 BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC. 214-0120-ST FB221002 00813954024776

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other