MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. BIA-GEN; MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE

Model Number	CS-MCCBA-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	01/12/2024
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.Patient previously diagnosed with spinal stenosis.Patient participated in a study in which the bia-gen bioactive product was utilized on (b)(6) 2023 for posterolatoeral spine surgery.Product implanted in location l4-l5.Other concomitant medical treatment was performed (l4-l5 laminectomy).Bone marrow aspirate, autograft and globus creo screws/sable tlif cage (not manufactured by collagen matrix, inc) were also utilized with the bia-gen product for the initial surgery.Customer stated the bia-gen product handled and performed excellent, and there were no notable complications noted during implantation.On a follow-up visit on (b)(6) 2024, patient reported pain/swelling in the right calf.The surgeon sent the patient for an ultrasound that revealed a partially occlusive deep vein thrombosis in the popliteal vein.Patient returned to emergency department on (b)(6) 2024 with shortness of breath and chest pain.Ct angiogram of the chest was performed and patient was diagnosed with pulmonary thromboembolism.The patient was admitted to the hospital on (b)(6) 2024 and discharged on (b)(6) 2024.The patient also completed a 6 month course of eliquis.Customer stated this was not an unexpected adverse event, and the event is unrelated to the intervention.The study intervention was not discontinued.It was noted the event stop date was 22july2024.There were no details provided surrounding teh event stop date.No further details surrounding patient status, patient outcome, or event will be provided.Customer also stated the reported incident was not related to the bia-gen product.

• Brand Name: BIA-GEN
• Common Device Name: MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE
• 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: 22188874
• Report Number: 2249852-2025-00009
• Device Sequence Number: 15671177
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110(17)260331(10)MCCBASAN230101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: 03/31/2026
• Device Model Number: CS-MCCBA-100
• Device Catalogue Number: CS-MCCBA-100
• Device Lot Number: MCCBASAN230101
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female