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

Model Number	DMS45
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a patient underwent a suboccipital craniectomy with dural repair using duramatrix suturable product.The graft was properly sutured and the suture line remained intact postoperatively.The patient initially recovered well.About 2-3 weeks after initial implantation, the central portion of the graft disintegrated despite the intact suture line.This unexpected degradation resulted in a pseudomeningocele.Revision surgery was required, in which a reoperation confirmed the suture line was intact but the center of the graft had disintegrated.Multiple subsequent procedures were required, including: replacement of the graft with duraguard (not a collagen matrix, inc.Product), placement of a ventricular catheter, and insertion of a vp shunt.Customer reported an event date of 10/20/2025 however it was not specified if this was the date of the initial surgery or the date of a subsequent procedure.Additional information was requested from the customer, including when all procedures occurred, how the unexpected graft degradation was discovered, and the patient outcome/patient status.The customer stated no further information regarding the event would 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: 23854947
• Report Number: 2249852-2025-00049
• Device Sequence Number: 17416379
• Product Code: GXQ
• UDI-Device Identifier: 00813954020426
• UDI-Public: (01)00813954020426(17)271130(10)2505023121
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 12/19/2025

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 Model Number: DMS45
• Device Catalogue Number: DMS45
• Device Lot Number: 2505023121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2025
• 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
• Patient Sex: Unknown