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

Model Number	DMOC33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Convulsion/Seizure (4406); Speech Disorder (4415)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A neurosurgeon reported to the distributor that the product involved is duramatrix-onlay conform, stating that "four patients now have come back presenting with headaches and one had a seizure".The neurosurgeon noted "all cases were craniotomies."one was a tumor, meningioma, middle fossa/csf leak, and subdural.This complaint pertains to patient #3, who underwent a craniotomy and subsequently experienced a headache and seizure.Postoperative imaging revealed inflammation around the dural graft site.The patient was diagnosed with fluid accumulation and infection, necessitating a return to the or approximately one month post op.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.Approximately two weeks later, the patient developed headaches, seizures, and dysarthria.Mr imaging showed dural enhancement with epidural fluid collection.There was a concern for active seizures, and the patient was started on medical therapy.The patient underwent repeat surgery on (b)(6) 2025 (repeat craniotomy for exploration) as the fluid collection did not decrease.Dura and dural graft were reportedly noted to be thickened.Cultures were taken which were positive.Patient overall did well.Based on the confirmed infection, repeat surgical intervention, and identification of the lot and item number, this complaint is reportable.However, clarification regarding the culture results, patient status post-revision, and attribution of procedural context to this specific case have not been provided.

• 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: 22568612
• Report Number: 2249852-2025-00040
• Device Sequence Number: 4021475
• Product Code: GXQ
• UDI-Device Identifier: 00813954026107
• UDI-Public: (01)00813954026107(17)260131(10)2307262022
• 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): 07/22/2025

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 Expiration Date: 01/31/2026
• Device Model Number: DMOC33
• Device Catalogue Number: DMOC33
• Device Lot Number: 2307262022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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
• Patient Sex: Unknown