MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. COPIOS EXTEND MEMBRANE; COLLAGEN DENTAL MEMBRANE V

Model Number	0192Z
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This adverse event occurred outside of the u.S.However, as there is a similar marketed device in the u.S., an mdr is being filed.Limited information provided.It was reported the copios extend membrane failed to integrate when tooth sites ur3 and ur4 were grafted together with the device.The patient experienced inflammation.Customer stated revision surgery will be required, as the patient will need to return to the office to complete the procedure.Additional information was requested, including patient information, event information, patient impact information, and information surrounding the revision surgery (patient outcome from revision surgery and date of revision surgery), however it was not provided.Additionally, no information surrounding potential device malfunction or further information surrounding patient impact was provided.No further information will be provided.
Additional Manufacturer Narrative
The complaint states the membrane failed to integrate.No integration is directly related to the thermal and ph properties of the product.Three units from reserve product inventoy were tested for thermal transition temperature determination, ph, and sterility.All test results met acceptance criteria and the product was proven to be sterile.This medical device report (mdr) is being submitted outside of the standard 30-day reporting timeframe due to corrective actions taken following a nonconformity identified during an mdsap audit/inspection.

• Brand Name: COPIOS EXTEND MEMBRANE
• Common Device Name: COLLAGEN DENTAL MEMBRANE V
• 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: 23812377
• Report Number: 2249852-2025-00050
• Device Sequence Number: 9409610
• Product Code: NPL
• UDI-Device Identifier: 00813954020556
• UDI-Public: (01)00813954020556(17)240331(10)PDMU22C1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: 03/31/2024
• Device Model Number: 0192Z
• Device Catalogue Number: 0192Z
• Device Lot Number: PDMU22C1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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 Age: 57 YR
• Patient Sex: Male