BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCORE

    MDR report key: 22418876 · Received July 7, 2025

    Report

    Report Number
    2249852-2025-00029
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    April 7, 2025
    Report Date
    July 7, 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 IS FOR SUSPECT DEVICE 1 AND IS THE PARENT MDR. REFER TO MDR 2249852-2025-00030 FOR SUSPECT DEVICE 2.

    Description of Event or Problem · 0

    COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY ADDITIONAL INFORMATION WILL BE PROVIDED. TWO BIOCORE PRODUCTS (DIFFERENT ITEM NUMBERS AND DIFFERENT LOT NUMBERS) WERE USED ON A PATIENT FOR POSTEROLATOERAL SPINAL SURGERY ON (B)(6) 2025. BIOCORE PRODUCTS WERE IMPLANTED IN LOCATIONS L3-L4 AND L4-L5 OF THE VERTEBRAE AND MIXED WITH BONE MARROW ASPIRATE AND AUTOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS). RODS, INVICTUS SCREWS, AND TWO CAGES WERE ALSO USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER CONFIRMED THERE WERE NO COMPLICATIONS NOTED DURING IMPLANTATION AND THE BIOCORE PRODUCTS HANDLED EXCELLENT. AT A 6-WEEK FOLLOW-UP APPOINTMENT ON (B)(6) 2025, AN ADVERSE EVENT OF SYSTEMIC WEIGHT LOSS WAS REPORTED, IN WHICH THE HAD A LOSS OF APPETITE AFTER SURGERY WITH SUBSEQUENT WEIGHT LOSS OF 28 POUNDS IN 6 WEEKS. THE PATIENT WAS REFERRED FOR A GASTRO ENTEROLOGIST CONSULTATION. THE FOLLOWING INTERVENTION TYPES WERE NOTED: ADD PROTEIN SHAKES TO THEIR DIET, KEEP A CALORIE COUNT, AND POSSIBLE THERAPY SESSIONS. NO FURTHER DETAILS SURROUNDING PATIENT OUTCOME OR PATIENT STATUS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10847 BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MQV COLLAGEN MATRIX, INC. 214-0120-ST FB221003 00813954024776

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other