BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCORE

    MDR report key: 22532890 · Received July 17, 2025

    Report

    Report Number
    2249852-2025-00033
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    April 16, 2025
    Report Date
    July 17, 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

    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. BIOCORE MOLDABLE BIOACTIVE GRAFT WAS USED IN A PATIENT FOR POSTEROLATERAL SPINE SURGERY ON (B)(6) 2024. THE GRAFT WAS PLACED IN VERTEBRAE LOCATIONS 3-4, 4-5 AND 5-S1 AND MIXED WITH BONE MARROW ASPIRATE AND AUTOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS). A CAGE AND INVICTUS SCREWS (NOT COLLAGEN MATRIX, INC. PRODUCTS) WERE ALSO USED IN CONJUNCTION WITH THE BIOCORE PRODUCT DURING THE INITIAL SURGERY. CUSTOMER STATED THE BIOCORE PRODUCT HANDLED AND PERFORMED EXCELLENT, AND THERE WERE NO NOTABLE COMPLICATIONS OBSERVED DURING IMPLANTATION. AT A ROUTINE 6-WEEK FOLLOW-UP VISIT ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN IN THEIR BACK OR LEGS. THE SPINAL FUSION BASED OFF RADIOGRAPH WAS CLASSIFIED AS SATISFACTORY. NO OTHER CONCOMITANT MEDICAL TREATMENTS WERE NOTED AND THERE WERE NO COMPLICATIONS OR ADVERSE EVENTS REPORTED AT THIS FOLLOW-UP VISIT. AT A ROUTINE 3-MONTH FOLLOW-UP VISIT ON (B)(6) 2025, PATIENT REPORTED PAIN IN THE LOWER BACK BUT NO PAIN IN EITHER LEG. THE SPINAL FUSION ASSESSMENT BASED ON RADIOGRAPH MAINTAINED A SATISFACTORY LEVEL. IT WAS NOTED THERE WAS COMPLETE RESOLUTION OF KNEE PAIN AT THIS TIME. PATIENT HAD A STEROID INJECTION AT THE 3-MONTH FOLLOW-UP AS WELL. PATIENT RETURNED ON (B)(6) 2025 IN WHICH THE ADVERSE EVENT WAS REPORTED. THE PATIENT WAS DIAGNOSED WITH SACROILIITIS IN THE LOWER BACK AND LEFT LEG, IN WHICH THE RETURN OF RADICULAR SYMPTOMS WAS NOTED, WITH AN ADVERSE EVENT ONSET DATE OF (B)(6) 2025. THIS WAS CLASSIFIED AS AN UNEXPECTED, BUT NOT SEVERE, ADVERSE EVENT. INTERVENTION INCLUDED LEFT SACROILIAC JOINT INJECTION OF CELESTONE AND MARCAINE PERFORMED ON (B)(6) 2025. MEDICATIONS WERE ALSO PRESCRIBED (FLEXERIL 5MG, IBUPROFEN 800MG AND MEDROL DOSEPAK). PRIOR TO THE (B)(6) 2025 VISIT, A CT OF THE LUMBAR SCAN WAS TAKEN ((B)(6) 2025) AND AN MR OF THE LUMBAR SPINE WAS TAKEN ((B)(6) 2025). NO FURTHER DETAILS SURROUNDING THE PATIENT STATUS, PATIENT OUTCOME, OR EVENT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615281 BIOCORE MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC. 214-0120-ST FB240501 00813954024776

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention