MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. SMARTGRAFT GRANULES; PORCINE ANOGRANIC BONE MINERAL

Model Number	114.101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medical device report (mdr) is being submitted outside of the standard 30-day reporting timeframe due to corrective actions taken following a non-conformity identified during an mdsap audit / inspection.Analysis of production records confirmed all non-routine and routine testing performed at time of release met acceptance criteria as specified in product specifications.No additional testing could be performed that would directly correlate with the issue identified in the reported complaint.
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.At time of complaint initiation, the customer reported a dehiscence was observed in a patient after the application of smartgraft in combination with smartbrane (not a collagen matrix, inc.Product) in the anterior area.No further information was provided at this time.Customer later provided additional information surrounding the incident.A generally healthy female patient underwent guided bone regeneration surgery on (b)(6) 2023, in which the smartgraft product was utilized for filling a "customer-made titanium mesh extra-orally" and was combined "with cross-linked hyaluronic acid and autologous bone in a 70%-30% ratio.Membranes were placed over the mesh, partially overlapping one another.The membranes used were not a collagen matrix, inc.Product.There were no complications noted during this initial procedure.A follow-up visit was conducted on (b)(6) 2023 and a mesh exposure measuring 4mm wide was observed.No significant pain or infections reported.Superficialization of some granules of the grafted material was noted.Interventaion required as a cutter was used to remove exposed portion of the mesh.No signs of infection noted.There was dispersion of grafted material, with superficial granules being removed as they surfaced.Another follow-up exam was conducted on (b)(6) 2023.Patient's clinical condition was stable.The exposed area was rinsed with a 0.9% saline solution, and additional migrated grafted granules were removed.Moderate inflammation noted at site of exposure, but no signs of infection or pain.The patient returned on (b)(6) 2023 for a cone beam computed tomography and patient underwent a routine examination.Patient's condition was stable.It was noted a few granules had surfaced and were removed as part of the ongoing management.Customer confirmed a complete removal of the mesh is scheduled for (b)(6) 2024.Patient has been instructed to apply aminogam at home.Additional information surrounding the follow-up and patient status was requested but not provided.No further information provided.

• Brand Name: SMARTGRAFT GRANULES
• Common Device Name: PORCINE ANOGRANIC BONE MINERAL
• 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: 23812050
• Report Number: 2249852-2025-00054
• Device Sequence Number: 15800002
• Product Code: NPM
• UDI-Device Identifier: 00813954023830
• UDI-Public: (01)00813954023830(17)231231(10)PMCU20P1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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: 12/31/2023
• Device Model Number: 114.101
• Device Catalogue Number: 114.101
• Device Lot Number: PMCU20P1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2020
• 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; Required Intervention
• Patient Sex: Female