BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMATRIX-ONLAY

    MDR report key: 23794930 · Received December 12, 2025

    Report

    Report Number
    2249852-2025-00063
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    January 2, 2025
    Report Date
    December 12, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K061487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED OUTSIDE THE STANDARD 30-DAY REPORTING TIMEFRAME DUE TO CORRECTIVE ACTIONS TAKEN FOLLOWING A NONCONFORMITY IDENTIFIED DURING AN MDSAP AUDIT /INSPECTION.

    Description of Event or Problem · 0

    THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILARLY MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. THE CUSTOMER INFORMED THE MANUFACTURER THAT A DURAMATRIX ONLAY PRODUCT WAS USED ON A PATIENT. THE SURGEON HAD TO PERFORM A REVISION SURGERY 3 WEEKS AFTER THE INITIAL SURGERY DUE TO A RECURRENT DURA LEAK. DATE OF REVISION SURGERY IS ASSUMED TO BE (B)(6) 2025, HOWEVER IT WAS NOT CONFIRMED. ADHERUS (NOT MANUFACTURED BY COLLAGEN MATRIX, INC.) WAS ALSO USED IN CONJUNCTION WITH THE DURAMATRIX ONLAY PRODUCT. THE PRODUCT ITEM AND LOT NUMBER WAS NOT PROVIDED. THE FOLLOWING INFORMATION WAS REQUESTED MULTIPLE TIMES BUT NOT PROVIDED: DETAILS SURROUNDING THE INITIAL PROCEDURE, ANY OBSERVATIONS WITH THE PRODUCT/PACKAGING, PRODUCT ITEM NUMBER, PRODUCT LOT NUMBER, DETAILS SURROUNDING REVISION SURGERY, AND CURRENT PATIENT STATUS/PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760151 DURAMATRIX-ONLAY DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE ONLAY GXQ COLLAGEN MATRIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R