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	Insufficient Information (4580)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
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.Product part of data collection is bia-gen¿ bioactive moldable bone graft matrix.The initial surgery was on (b)(6) 2022.Two products of bia-gen were used on a patient during initial surgery.The product was used in the posterolatoeral spine in l2-l3, l3-l4.Bia-gen was mixed with allograft and autograft (no specific details on allograft and autograft products provided and cmi does not manufacture or distributed allograft products).Other products used in conjunction were expandable spacer 10x28x8-13mm, screw, curved rod, locking screw (cmi does not manufacture these products).There were no complications during implantation, no other concomitant medical treatment and the overall handling and performance were rated "4-excellent".Patient reported post operative pain, right sided sciatica.The adverse event onset date was 09/17/2022.The subject complained of having right upper leg numbness and pinching and was advised by on-call doctor to go to the emergency department to rule out a possible deep vein thrombosis (dvt).Subject provided stool softener; antibiotic for incision site redness and was discharged on the same day.The medical intervention type included medications, bactrim ds; co-trimoxazole ds; 800-160 mg per tablet docusate sodium (colace) 100 mg capsule.No further information surrounding patient status or patient outcome was provided.
Additional Manufacturer Narrative
This mdr 2249852-2025-00018 is for suspect device 1 and is the parent mdr.Please refer to mdr 2249852-2025-00019 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: 22326928
• Report Number: 2249852-2025-00018
• Device Sequence Number: 9418165
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 02/28/2025
• Device Model Number: CS-MCCBA-100
• Device Catalogue Number: CS-MCCBA-100
• Device Lot Number: MCCBASA22A2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown