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

Model Number	CDSLM45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint submitted through clinical data collection.Limited information provided and it is unlikely further information surrounding the patient or the event will be provided.Duramatrx-onlay collagen dura membrane used on a patient on (b)((6) 2025 in the anterior fossa.Patient was part of clinical study for meningioma who grade 1.At time of initial surgery, 3-0 and 4-0 synthetic, non-absorbable sutures were used (not collagen matrix, inc.Products).No other dural products were utilized.A drainage shunt was also used (not a collagen matrix, inc.Product).There were no complications noted during the initial surgery.There was no csf leakage after initial placement.The clinician classified the handling properties of the duramatrix-onlay product as "good" and also classified the adaptability of the product to anatomic structure as "good." an adverse event was reported on 5/31/2025, in which an intracranial abscess post craniectomy in the bone flap was noted.Clinician classified this as a serious, but unexpected, adverse event.Hospitalization was required.Intervention required as additional surgery was performed to re-do the craniectomy and evacuation of abscess and washout.A ct/mri was performed but no further details were provided.The dural defect site upon re-enty was adequate.Customer listed (b)(6) 2025 as the adverse event stop date, however no details surrounding this were provided.A routine follow-up was performed on (b)(6) 2025 and no further adverse events were noted; clinician was satisfied with the performance of the duramatrix-onlay device.No further details surrounding the patient status, patient outcome, or event will be provided.

• Brand Name: DURAMATRIX-ONLAY COLLAGEN DURA MEMBRANE
• Common Device Name: COLLAGEN DURA SUBSTITUTE MEMBRANES
• 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: 22560140
• Report Number: 2249852-2025-00034
• Device Sequence Number: 9565358
• Product Code: GXQ
• UDI-Device Identifier: 00813954020273
• UDI-Public: (01)00813954020273(17)271231(10)2412131022
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: 2412131022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2024
• 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 Age: 80 YR
• Patient Sex: Male