BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA-GEN

    MDR report key: 22198086 · Received June 12, 2025

    Report

    Report Number
    2249852-2025-00011
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    July 15, 2024
    Report Date
    June 12, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    MQV
    UDI-DI
    00813954024110
    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 SITE. LIMITED INFORMATION PROVIDED. PATIENT UNDERWENT POSTEROLATOERAL SPINAL SURGERY ON (B)(6) 2024. THE BIA-GEN MOLDABLE BONE GRAFT MATRIX PRODUCT WAS PLACED IN VERTEBRAE LOCATION L4-L5. AUOGRAFT AND OTHER HARDWARE (NOT MANUFACTURED OR DISTRIBUTED BY COLLAGEN MATRIX, INC.) WERE USED IN CONJUNCTION WITH THE BIA-GEN PRODUCT. A TLIF AND LAMINECTOMY WERE REPORTED AS OTHER CONCOMITANT MEDICAL TREATMENT. THERE WERE NO COMPLICATIONS NOTED DURING THE INITIAL PROCEDURE AND THE CLINICIAN NOTED THE BIA-GEN PRODUCT PERFORMED AND HANDLED EXCELLENT. ON (B)(6) 2024 DURING A PLANNED FOLLOW-UP VISIT, IT WAS NOTED THE PATIENT FELL (EXACT DETAILS OF FALL NOT SPECIFIED OR PROVIDED), WITH INJURY TO HER LEG AND BACK, AND HAS HAD WORSENING BACK PAIN SINCE FALLING. A CT SCAN AND MRI WAS PERFORMED ON PATIENT, INDICATING LOWER BACK PAIN WITH SOME RADICULAR COMPONENT. THE PATIENT WAS PRESCRIBED MEDICATION (OXYCODONE; DOSAGE NOT SPECIFIED), PHYSICAL THERAPY, AND REST. CLINICIAN NOTED THEY DID NOT CONSIDER THIS TO BE A SERIOUS ADVERSE EVENT, AND THE REPORTED EVENT IS NOT RELATED TO THE BIA-GEN PRODUCT. NO ADDITIONAL INFORMATION SURROUNDING PATIENT STATUS, PATIENT OUTCOME, OR EVEN INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202058 BIA-GEN MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC. CS-MCCBA-100 MCCBASAN230101 00813954024110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other