MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX ONLAY; DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE-ONLAY

Model Number	CDSLM45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint submitted through clinical data collection, with limited details provided.Further information regarding the patient or event is unlikely to become available.The product involved is duramatrix-onlay®.A patient experienced an adverse event (ae) characterized as wound dehiscence with purulent discharge.The initial surgery was (b)(6) 2025 and the location of the implant was the anterior fossa.No sutures, sealants or other dural closure products were used during the procedure.No csf leak was observed post-placement.A drainage shunt was used.A routine follow up visit on (b)(6) 2025 noted no adverse events.However, a subsequent follow-up visit on (b)(6) 2025 indicated wound dehiscence on the "scalp, wound".The patient was initially prescribed cephalexin which was switched to doxycycline due to sensitivities.Clinical data collection indicated that the adverse event was unrelated to the intervention.No surgical intervention was required.No further information surrounding patient status or patient outcome was provided.

• Brand Name: DURAMATRIX ONLAY
• Common Device Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE-ONLAY
• 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: 22568587
• Report Number: 2249852-2025-00035
• Device Sequence Number: 3811117
• Product Code: GXQ
• UDI-Device Identifier: 00813954020273
• UDI-Public: (01)00813954020273(17)271130(10)2411223022
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: CDSLM45
• Device Catalogue Number: CDSLM45
• Device Lot Number: 2411223022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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