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	Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2024
Type of Reportable Event	Death
Event or Problem Description
Complaint submitted through clinical data collection.Limited information provided.Patient was involved in a clinical study for pseudoclaudication syndrome.Initial surgery was performed on (b)(6) 2024 utilizing the bia-gen bioactive moldable bone graft matrix.The product was placed in vertebrae locations l2-l3-l4-l5.There were no other products used in conjunction with bia-gen during the initial surgery and no complications noted.The clinician noted the prdouct had handled and performed excellent.On (b)(6) 2024, the patient went to the emergency department for emesis, left foot swelling and epigastric discomfort.Patient then became pale, unresponsive, and expired.Clinician believes cause of death to be cardiac arrest, hypoxic arrest, or a missed myocardial infraction.Clinician stated the serious adverse event is unrelated to the bia-gen product.No further information surrounding patient information and event will be provided.

• 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: 22197618
• Report Number: 2249852-2025-00010
• Device Sequence Number: 9739317
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110(17)250228(10)MCCBASAN22A2
• 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: 2024
• 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): 06/12/2025

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
• Device Expiration Date: 02/26/2025
• Device Model Number: CS-MCCBA-100
• Device Catalogue Number: CS-MCCBA-100
• Device Lot Number: MCCBASAN22A2
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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: Death
• Patient Age: 80 YR
• Patient Sex: Male