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)
Date of Event	04/26/2025
Type of Reportable Event	Serious Injury
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 posterolatoeral 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 durign 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.
Additional Manufacturer Narrative
This mdr is for suspect device 1 and is the parent mdr.Refer to mdr 2249852-2025-00028 for suspect device 2.

• 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: 22413168
• Report Number: 2249852-2025-00027
• Device Sequence Number: 8257114
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110(17)270430(10)BASN240103
• 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
• Report Source: Other
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CS-MCCBA-100
• Device Catalogue Number: CS-MCCBA-100
• Device Lot Number: BASN240103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• 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: 04/04/2024
• 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: 79 YR
• Patient Sex: Male