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 Code	Headache (1880)
Date of Event	04/08/2025
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 a subdural.This complaint pertains to patient #2, 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.An extended stay in the hospital was indicated but noted worsening headaches about 1 week after surgery.Mr imaging showed dural enhancement around the operative site and epidural fluid.This was managed nonoperatively.Headaches improved over a few weeks with subsequent scans showing decreasing fluid.Patient overall did well.No further details regarding the patient's status following symptom resolution have 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: 22568594
• Report Number: 2249852-2025-00039
• Device Sequence Number: 3811121
• Product Code: GXQ
• UDI-Device Identifier: 00813954026107
• UDI-Public: (01)00813954026107(17)261130(10)2405061022
• 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 Model Number: DMOC33
• Device Catalogue Number: DMOC33
• Device Lot Number: 2405061022
• 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: 05/06/2024
• 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; Hospitalization
• Patient Sex: Unknown