MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE

Model Number	DMS22
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This adverse event occurred outside of the u.S.However, as there is a similarly marketed device in the u.S., an mdr is being filed.Limited information surrounding the event was provided.The customer informed the manufacturer that the duramatrix suturable product was utilized on a patient during an initial surgery on (b)(6) 2023.7 months after the initial surgery, revision surgery was performed on (b)(6) 2024 and it was found that the duramatrix suturable patch did not resorb.The patch "was almost intact." the following information was requested but not provided: information surrounding the initial surgery (including nature of surgery), reason for the revision surgery, surgical technique information, current patient status, and if there are any follow-up visits scheduled.Revision surgery was required for the patient, however details surrounding the reason for the revision surgery were not provided.Information surrounding patient status was requested but not provided.Complainant confirmed the patient "did not feel any discomfort caused by the patch.The following information was requested: information surrounding the initial surgery, reason for the revision surgery, surgical technique information, current patient status, and if there are any follow-up visits scheduled.Multiple attempts were made to gather additional information however no further information was provided.
Additional Manufacturer Narrative
This medical device report (mdr) is being submitted outside the standard 30-day reporting timeframe due to corrective actions taken following a nonconformity identified during an mdsap audit /inspection.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• 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: 23794895
• Report Number: 2249852-2025-00060
• Device Sequence Number: 5571423
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: (01)00813954020402(17)260131(10)2307281121
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: DMS22
• Device Catalogue Number: DMS22
• Device Lot Number: 2307281121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• 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; Other
• Patient Sex: Unknown