MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX-ONLAY PLUS; COLLAGEN DURAL REGENERATION MATRIX

Model Number	DMOP11
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
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.
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.It was reported that a duramatrix had been mistakenly used in a patient's hand instead of a bone graft.The nurse grabbed the wrong product.Procedure was completed successfully.Surgeon has no concerns provided the graft dissolves and is absorbed into the body.No further adverse patient outcomes/consequences reported.The device was not returned for investigation.The device history and complaint history records were reviewed and confirmed that the device was manufactured to specification.The product labelling and packaging from the reported lot was reviewed and found to be conforming.Per the product's instructions for use, the device is designed for use in cranial or spinal procedures where primary suture closure of the dural defect may not be feasible.If any additional information is provided, the investigation will be reassessed.Product surveillance will continue to monitor for trends.

• Brand Name: DURAMATRIX-ONLAY PLUS
• Common Device Name: COLLAGEN DURAL REGENERATION MATRIX
• 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: 23794894
• Report Number: 2249852-2025-00064
• Device Sequence Number: 20226647
• Product Code: GXQ
• UDI-Device Identifier: 00813954021263
• UDI-Public: (01)00813954021263(17)260831(10)2308031022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: DMOP11
• Device Catalogue Number: DMOP11
• Device Lot Number: 2308031022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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: Other
• Patient Sex: Unknown