BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIA-GEN

    MDR report key: 22197618 · Received June 12, 2025

    Report

    Report Number
    2249852-2025-00010
    Event Type
    Death
    Date Received
    June 12, 2025
    Date of Event
    November 20, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED. PATIENT WAS INVOLVED IN A CLINICAL STUDY FOR PSEUDOCLAUDICATION SYNDROME. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024 UTILIZING THE BIA-GEN BIOACTIVE MOLDABLE BONE GRAFT MATRIX. THE PRODUCT WAS PLACED IN VERTEBRAE LOCATIONS L2-L3-L4-L5. THERE WERE NO OTHER PRODUCTS USED IN CONJUNCTION WITH BIA-GEN DURING THE INITIAL SURGERY AND NO COMPLICATIONS NOTED. THE CLINICIAN NOTED THE PRDOUCT HAD HANDLED AND PERFORMED EXCELLENT. ON (B)(6) 2024, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR EMESIS, LEFT FOOT SWELLING AND EPIGASTRIC DISCOMFORT. PATIENT THEN BECAME PALE, UNRESPONSIVE, AND EXPIRED. CLINICIAN BELIEVES CAUSE OF DEATH TO BE CARDIAC ARREST, HYPOXIC ARREST, OR A MISSED MYOCARDIAL INFRACTION. CLINICIAN STATED THE SERIOUS ADVERSE EVENT IS UNRELATED TO THE BIA-GEN PRODUCT. NO FURTHER INFORMATION SURROUNDING PATIENT INFORMATION AND EVENT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033385 BIA-GEN MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC. CS-MCCBA-100 MCCBASAN22A2 00813954024110

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death