MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX ONLAY CONFORM; DURAFORM DURAL GRAFT IMPLANT

Model Number	DMOC22
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Speech Disorder (4415)
Type of Reportable Event	Serious Injury
Event or Problem Description
At the time of the initial complaint, limited information was provided for the initial complaint.A neurosurgeon reported to the distributor that the product involved is duramatrix-onlay conform, noting that "four patients now have come back presenting with headaches and one had a seizure.In post-operation craniotomy scans, it showed inflammation around the dural graft site.The patient who presented with a seizure had fluid and was infected, leading to a take-back to the or a month later." the neurosurgeon noted "all cases were craniotomies."one was a tumor, meningioma, middle fossa/csf leak, and a subdural.This complaint pertains to patient #1, who underwent a craniotomy and subsequently experienced a headache.Additional information was received on 07/07/2025.The lot number and item number have been provided.The initial surgery was on (b)(6) 2025.The patient developed headaches and dysarthria roughly 1 week later.The patient presented to the emergency department (ed).Mr imaging showed dural enhancement around the operative site.There was a concern for seizures and the patient was started on medical therapy.Was monitored in the hospital for a few days and symptoms slowly and completely resolved.Patient overall did well.

• Brand Name: DURAMATRIX ONLAY CONFORM
• Common Device Name: DURAFORM DURAL GRAFT IMPLANT
• 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: 22506284
• Report Number: 2249852-2025-00031
• Device Sequence Number: 8745472
• Product Code: GXQ
• UDI-Device Identifier: 00813954026084
• UDI-Public: 00813954026084
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152481
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: DMOC22
• Device Catalogue Number: DMOC22
• Device Lot Number: 2406251022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown