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

Model Number	CS-MCCBA100
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperplasia (1906); Muscle Weakness/Atrophy (1967); Urinary Retention (2119); Syncope/Fainting (4411)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is for suspect device 2.Please refer to the parent mdr 2249852-2026-00001 for suspect device 1.
Event or Problem Description
Complaint submitted through clinical data collection.Limited information provided and it is unlikely further information surrounding the patient or event will be provided.Two bia-gen products (different lot numbers) were used.Bia-gen was used in a posterolatoeral spine (location (l2 to l5) surgery on (b)(6) 2025.There are five different adverse events associated with this patient.Only one of the adverse events is classified as having a possible relation to the intervention.At the 6 month visit, the patient presented with weakness in bilateral lower extremities and multiple falls over a week and a half and 3 days of worsening back pain with numbness and tingling.Mri lumbar spine showed degenerative changes but no cord compression.In the setting of deconditioning from recent hospital stay.The adverse event onset date was (b)(6) 2025.The relationship of the event to intervention has been categorized as "possible".The intervention included outpatient physical therapy to continue.The adverse event stop date was indicated as (b)(6) 2025.On (b)(6) 2025, the patient experienced urinary catheter dysfunction.A dime sized clot was found and flushed.Intervention included lidocaine 2% jell, foley catheter was exchanged.The adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.The patient experienced an additional adverse event with the onset date of september 30, 2025.On (b)(6) 2025 the patient presented for a holep procedure.Decision was made to go home with foley catheter post-procedure.There were no complications to the procedure.The adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.On (b)(6) 2025, the patient experienced urinary retention since the night prior.The patient noticed leaking with mild pressure to his suprapubic region.Drainage discontinued.Intervention included tramadol and lab work.The catheter was irrigated and foley removed.The adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.On (b)(6) 2025, the patient experienced syncope.The patient was sitting on a chair having lunch when they felt dizzy as if they were going to pass out.Ems reported patient was hypotensive and diaphoretic.Patient was asymptomatic in the ed.Intervention included iv hydration, placed on cardiac monitor and ekg, d-dimer, ct head/chest, x-ray, lab testing.This adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.No further details surrounding patient outcome or patient status will be provided.
Additional Manufacturer Narrative
The clinician confirmed the event is unrelated to the manufacturer's product.
Event or Problem Description
Complaint submitted through clinical data collection.Limited information provided and it is unlikely further information surrounding the patient or event will be provided.Two bia-gen products (different lot numbers) were used.Bia-gen was used in a posterolatoeral spine (location (l2 to l5) surgery on (b)(6) 2025.There are five different adverse events associated with this patient.Only one of the adverse events is classified as having a possible relation to the intervention.At the 6 month visit, the patient presented with weakness in bilateral lower extremities and multiple falls over a week and a half and 3 days of worsening back pain with numbness and tingling.Mri lumbar spine showed degenerative changes but no cord compression.In the setting of deconditioning from recent hospital stay.The adverse event onset date was (b)(6) 2025.The relationship of the event to intervention has been categorized as "possible".The intervention included outpatient physical therapy to continue.The adverse event stop date was indicated as (b)(6) 2025.On (b)(6) 2025, the patient experienced urinary catheter dysfunction.A dime sized clot was found and flushed.Intervention included lidocaine 2% jell, foley catheter was exchanged.The adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.The patient experienced an additional adverse event with the onset date of september 30, 2025.On (b)(6) 2025 the patient presented for a holep procedure.Decision was made to go home with foley catheter post-procedure.There were no complications to the procedure.The adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.On (b)(6) 2025, the patient experienced urinary retention since the night prior.The patient noticed leaking with mild pressure to his suprapubic region.Drainage discontinued.Intervention included tramadol and lab work.The catheter was irrigated and folely removed.The adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.On (b)(6) 2025, the patient experienced syncope.The patient was sitting on a chair having lunch when they felt dizzy as if they were going to pass out.Ems reported patient was hypotensive and diaphoretic.Patient was asymptomatic in the ed.Intervention included iv hydration, placed on cardiac monitor and ekg, d-dimer, ct head/chest, x-ray, lab testing.This adverse event is considered unrelated to the intervention.The adverse event stop date was indicated as (b)(6) 2025.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: 24020707
• Report Number: 2249852-2026-00002
• Device Sequence Number: 18780208
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: CS-MCCBA100
• Device Catalogue Number: CS-MCCBA100
• Device Lot Number: BASN240103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/13/2026
• 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: Hospitalization; Other
• Patient Sex: Unknown