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 Code	Back pain (4895)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint submitted through clinical data collection site.Limited information provided.Patient underwent posterolatoeral spinal surgery on (b)(6) 2024.The bia-gen moldable bone graft matrix product was placed in vertebrae location l4-l5.Auograft and other hardware (not manufactured or distributed by collagen matrix, inc.) were used in conjunction with the bia-gen product.A tlif and laminectomy were reported as other concomitant medical treatment.There were no complications noted during the initial procedure and the clinician noted the bia-gen product performed and handled excellent.On (b)(6) 2024 during a planned follow-up visit, it was noted the patient fell (exact details of fall not specified or provided), with injury to her leg and back, and has had worsening back pain since falling.A ct scan and mri was performed on patient, indicating lower back pain with some radicular component.The patient was prescribed medication (oxycodone; dosage not specified), physical therapy, and rest.Clinician noted they did not consider this to be a serious adverse event, and the reported event is not related to the bia-gen product.No additional information surrounding patient status, patient outcome, or even information 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: 22198086
• Report Number: 2249852-2025-00011
• Device Sequence Number: 15780753
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110(17)260331(10)MCCBASAN230101
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 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: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Female