MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; K141608

Model Number	DMS45
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was provided.Customer stated the duramatrix suturable product was used on a patient in 2019 (date and nature of procedure not specified).Patient was "reopened" on (b)(6) 2025 and there was a massive hole in the graft and csf was leaking out.No details surrounding this second operation were provided.Additional information was requested, including was the second operation conducted as medical intervention to address the csf leakage, what was the second operation performed, and current patient status.No further information has been provided.As it was confirmed intervention was required and a second operation was performed, this event is being reported.
Additional Manufacturer Narrative
Quality assurance reviewed all processes associated with the reported event and confirmed all routine product testing were found conforming.
Event or Problem Description
Customer stated a hole in the duramatrix suturable product was observed and csf was leaking out.The graft was originally used on a patient in 2019 (specific date and nature of original procedure not specified).The patient had a reoccurring tumor, hence the need for a second procedure.The second procedure was a craniotomy performed on (b)(6) 2025 in which the patient was reopened.Csf was leaking out and a hole in the graft was observed during this second procedure.No information surrounding the patient status or further details surrounding the second procedure were provided.As it was confirmed intervention was required and a second operation was performed, this event is being reported.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: K141608
• 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: 24146750
• Report Number: 2249852-2026-00004
• Device Sequence Number: 18480835
• Product Code: GXQ
• UDI-Device Identifier: 00813954020426
• UDI-Public: (01)00813954020426(17)200430(10)1810271121
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 04/30/2020
• Device Model Number: DMS45
• Device Catalogue Number: DMS45
• Device Lot Number: 1810271121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/06/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/04/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown