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

Model Number	CS-MCCBA-100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr.Is for suspect device 2.Please refer to the parent mdr 2249852-2025-00027 for suspect device 1.
Event or Problem Description
Complaint was submitted through clinical data collection.Limited information provided and it is unlikely additional information surrounding the event or patient will be provided.Patient went for posterolateral spine surgery on (b)(6) 2025.Two units (from two different lots) of the bia-gen bioactive moldable bone graft matrix were used on the patient in vertebrae location l4-l5.The bia-gen was also mixed with an autograft and allograft (not collagen matrix, inc.Products; specific product information not provided).There were also l2-l5 pedicle screws and rods used during the initial procedure (not collagen matrix, inc products).Customer confirmed there were no complications noted during implantation and the product performed excellent.At the scheduled 3-month follow-up visit, an unexpected adverse event was reported on (b)(6) 2025, in which the patient went outside and hit his head.The laceration site became infected.The customer did not categorize this as a serious adverse event.The patient was prescribed keflex for the infection and sutures and staples were used to close the laceration.The customer confirmed this event was not related to the intervention.No further details surrounding patient outcome or patient status 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: 22413170
• Report Number: 2249852-2025-00028
• Device Sequence Number: 9692378
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110(17)260331(10)MCCBASAN230101
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K182074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown