BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA-GEN

    MDR report key: 22413168 · Received July 7, 2025

    Report

    Report Number
    2249852-2025-00027
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    April 26, 2025
    Report Date
    July 7, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    MQV
    UDI-DI
    00813954024110
    PMA / PMN Number
    K182074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS FOR SUSPECT DEVICE 1 AND IS THE PARENT MDR. REFER TO MDR 2249852-2025-00028 FOR SUSPECT DEVICE 2.

    Description of Event or Problem · 0

    COMPLAINT WAS SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY ADDITIONAL INFORMATION SURROUNDING THE EVENT OR PATIENT WILL BE PROVIDED. PATIENT WENT FOR POSTEROLATOERAL SPINE SURGERY ON (B)(6) 2025. TWO UNITS (FROM TWO DIFFERENT LOTS) OF THE BIA-GEN BIOACTIVE MOLDABLE BONE GRAFT MATRIX WERE USED ON THE PATIENT IN VERTEBRAE LOCATION L4-L5. THE BIA-GEN WAS ALSO MIXED WITH AN AUTOGRAFT AND ALLOGRAFT (NOT COLLAGEN MATRIX, INC. PRODUCTS; SPECIFIC PRODUCT INFORMATION NOT PROVIDED). THERE WERE ALSO L2-L5 PEDICLE SCREWS AND RODS USED DURING THE INITIAL PROCEDURE (NOT COLLAGEN MATRIX, INC. PRODUCTS). CUSTOMER CONFIRMED THERE WERE NO COMPLICATIONS NOTED DURIGN IMPLANTATION AND THE PRODUCT PERFORMED EXCELLENT. AT THE SCHEDULED 3-MONTH FOLLOW-UP VISIT, AN UNEXPECTED ADVERSE EVENT WAS REPORTED ON (B)(6) 2025, IN WHICH THE PATIENT WENT OUTSIDE AND HIT HIS HEAD. THE LACERATION SITE BECAME INFECTED. THE CUSTOMER DID NOT CATEGORIZE THIS AS A SERIOUS ADVERSE EVENT. THE PATIENT WAS PRESCRIBED KEFLEX FOR THE INFECTION AND SUTURES AND STAPLES WERE USED TO CLOSE THE LACERATION. THE CUSTOMER CONFIRMED THIS EVENT WAS NOT RELATED TO THE INTERVENTION. NO FURTHER DETAILS SURROUNDING PATIENT OUTCOME OR PATIENT STATUS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153670 BIA-GEN MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE MQV COLLAGEN MATRIX, INC. CS-MCCBA-100 BASN240103 00813954024110

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other