MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE

Model Number	DMS13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 22580901
• Report Number: 2249852-2025-00032
• Device Sequence Number: 7157688
• Product Code: GXQ
• UDI-Device Identifier: 00813954020396
• UDI-Public: (01)00813954020396(17)251130(10)2305251121
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/30/2025
• Device Model Number: DMS13
• Device Catalogue Number: DMS13
• Device Lot Number: 2305251121
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown