MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. BIA-GEN BIOACTIVE; 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	Pain (1994)
Date of Event	05/01/2024
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 the event will be provided.Patient was part of clinical study as they were prevoiusly diagnosed with spondylolisthese in the lumbar region.Patient was also has a history of right knee arthritis.Bia-gen bioactive mineral collagen composite bioactive moldable strip product was used on patient for an unspecified surgery on (b)(6) 2023.The surgery was likley related to the spondylolisthese diagnosis.It was reported on (b)(6) 2024 the patient exhibited right hip pain in the groin, likely coming from the hip socket.Customer stated this was not an unexpected adverse event and did not consider this pain to be a severe adverse event.The intervention recommended was hip injection under fluoroscopic guidance and a referrel to total joint surgery; it was not specified when this intervention was started or completed.After consultation and mri with the total joint surgery specialist (date not specified), the patient was found to have "moderate hip joint arthrosis with superior labral tear and 8mm cyst over the lateral acetabulum." patient was prescribed over the counter pain meds (type of medication not specified), rest, and cortisone injection.No further details surrounding the steps taken to treat the event were provided.There was no further information provided on patient status or patient outcome and no additional information will be provided.

• Brand Name: BIA-GEN BIOACTIVE
• 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: 22181534
• Report Number: 2249852-2025-00008
• Device Sequence Number: 8570463
• Product Code: MQV
• UDI-Device Identifier: 00813954024110
• UDI-Public: (01)00813954024110(17)260331(10)MCCBASAN221203
• 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: 2023
• 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): 06/10/2025

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: MCCBASAN221203
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 06/10/2025
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male