BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMATRIX SUTURABLE

    MDR report key: 22580901 · Received July 23, 2025

    Report

    Report Number
    2249852-2025-00032
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    March 28, 2025
    Report Date
    August 14, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    UDI-DI
    00813954020396
    PMA / PMN Number
    K141608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A MEDWATCH FORM, MW5171348, WAS RECEIVED BY COLLAGEN MATRIX, INC. ON JUNE 24, 2025. THE MEDWATCH FORM INDICATES THAT A DURAMATRIX GRAFT WAS USED ON A PATIENT FOR A CRANIECTOMY ON (B)(6) 2025. TISSEEL FIBRIN GLUE (NOT A COLLAGEN MATRIX, INC. PRODUCT) WAS ALSO USED DURING THIS INITIAL PROCEDURE. VARIOUS REVISIONS AND MEDICAL INTERVENTIONS TOOK PLACE AFTER THE INITIAL GRAFT PLACEMENT. DURAL REPAIR, WOUND EXPLORATION AND DEBRIDEMENT OCCURRED ON (B)(6) 2025. A LUMBAR DRAIN PLACEMENT WAS PERFORMED ON (B)(6) 2025 AND SUBSEQUENTLY REMOVED ON (B)(6) 2025. A LUMBAR DRAIN REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION AT THE SITE OF THE SURGERY AND THE GRAFT WAS EXPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE REPLACEMENT LUMBAR DRAIN WAS REMOVED. CULTURES FROM THE GRAFT WERE POSITIVE FOR ASPERGILLUS. A (B)(6) 2025 CULTURE OBTAINED FROM AN ASPIRATE AT THE BACK OF THE PATIENT'S NECK GREW ASPERGILLUS. ADDITIONALLY, CULTURES OBTAINED FROM THE (B)(6) 2025 EXPLANTED GRAFT ALSO TESTED POSITIVE FOR ASPERGILLUS. VARIOUS MEDICATIONS WERE PRESCRIBED TO THE PATIENT. FOR THE GROWTH OF METHICILLIN (SUSCEPTIBLE STAPHYLOCOCCUS AUREUS), THE FOLLOWING WAS PRESCRIBED: VANCOMYCIN (FROM (B)(6) 2025), CEFEPIME (B)(6) 2025), AND LINEZOLID (B)(6) 2025). FOR ASPERGILLUS FUMIGATUS, THE FOLLOWING WAS PRESCRIBED: LIPOSOMAL AMPHOTERICIN B (B)(6) 2025) AND VORICONAZOLE (B)(6) 2025-PRESENT; ANTICIPATED COURSE IS 3-6 MONTHS). DOSAGES OF THE MEDICATIONS WAS NOT PROVIDED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THE PATIENT CURRENTLY REMAINS ON ANTIFUNGAL. THE PATIENT HAS ADDIITONAL FOLLOW-UP APPOINTMENTS FOR A REPEAT BRAIN MRI HOWEVER THERE WERE NO DETAILS SURROUNDING THE ANCITPATED DATE OF THE FOLLOW-UP APPOINTMENT PROVIDED.

    Description of Event or Problem · 0

    A MEDWATCH FORM, MW5171348, WAS RECEIVED BY COLLAGEN MATRIX, INC. ON JUNE 24, 2025. THE MEDWATCH FORM INDICATES THAT A DURAMATRIX GRAFT WAS USED ON A PATIENT FOR A CRANIECTOMY ON (B)(6) 2025. TISSEEL FIBRIN GLUE (NOT A COLLAGEN MATRIX, INC. PRODUCT) WAS ALSO USED DURING THIS INITIAL PROCEDURE. VARIOUS REVISIONS AND MEDICAL INTERVENTIONS TOOK PLACE AFTER THE INITIAL GRAFT PLACEMENT. DURAL REPAIR, WOUND EXPLORATION AND DEBRIDEMENT OCCURRED ON (B)(6) 2025. A LUMBAR DRAIN PLACEMENT WAS PERFORMED ON (B)(6) 2025 AND SUBSEQUENTLY REMOVED ON (B)(6) 2025. A LUMBAR DRAIN REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION AT THE SITE OF THE SURGERY AND THE GRAFT WAS EXPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE REPLACEMENT LUMBAR DRAIN WAS REMOVED. CULTURES FROM THE GRAFT WERE POSITIVE FOR ASPERGILLUS. A (B)(6) 2025 CULTURE OBTAINED FROM AN ASPIRATE AT THE BACK OF THE PATIENT'S NECK GREW ASPERGILLUS. ADDITIONALLY, CULTURES OBTAINED FROM THE (B)(6) 2025 EXPLANTED GRAFT ALSO TESTED POSITIVE FOR ASPERGILLUS. VARIOUS MEDICATIONS WERE PRESCRIBED TO THE PATIENT. FOR THE GROWTH OF METHICILLIN (SUSCEPTIBLE STAPHYLOCOCCUS AUREUS), THE FOLLOWING WAS PRESCRIBED: VANCOMYCIN (FROM (B)(6) 2025), CEFEPIME (B)(6) 2025), AND LINEZOLID ((B)(6) 2025). FOR ASPERGILLUS FUMIGATUS, THE FOLLOWING WAS PRESCRIBED: LIPOSOMAL AMPHOTERICIN B ((B)(6) 2025) AND VORICONAZOLE ((B)(6) 2025-PRESENT; ANTICIPATED COURSE IS 3-6 MONTHS). DOSAGES OF THE MEDICATIONS WAS NOT PROVIDED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THE PATIENT CURRENTLY REMAINS ON ANTIFUNGAL. THE PATIENT HAS HAD VARIOUS ADDITIONAL CLINICAL FOLLOW-UP APPOINTMENTS FOR A REPEAT BRAIN MRI. THE DATES OF THE FOLLOW-UP APPOINTMENTS WERE NOT PROVIDED, AND LIMITED INFORMATION SURROUNDING THE NATURE/OUTCOME OF THE FOLLOW-UP APPOINTMENTS WERE PROVIDED. THE CUSTOMER DID CONFIRM THE MRI "LOOKS GOOD IN REGARD TO THE INFECTION" AND THAT THE PATIENT IS "CLINICALLY IMPROVING - STILL CHRONICALLY ILL APPEARING BUT MAKING PROGRESS WITH THERAPIES, WORKING TO GAIN BACK HER WEIGHT LOSS AND STRENGTH." NO FURTHER DETAILS SURROUNDING PATIENT STATUS OR NEXT STEPS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25719 DURAMATRIX SUTURABLE COLLAGEN DURA MEMBRANE GXQ COLLAGEN MATRIX, INC. DMS13 2305251121 00813954020396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H