MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. BIOCORE; MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE

Model Number	214-0060-ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This parent mdr is mdr.This mdr is for suspect device 2.
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 diagnosed with chronic lower backpain.Two items of the biocore mineral collagen composite bioactive moldable were used on a patient during initial surgery on (b)(6) 2024.Product was implanted in patient in location l3-4 and l4-5.A bone marrow aspirate and allograft (not collagen matrix, inc.Products) were used in conjunction with the biocore bioactive product.Additionally, it was reported that invictus screws and a cage was also used (not collagen matrix, inc.Products).Customer reported no complications were noted during implant and the product handled and performed excellent.On (b)(6) 2024 there was mild anterior subsidence of the l4-l5 cage into the anterior l5 vertebral body.Customer confirmed this was not a serious adverse event and reported physical therapy as the behavioral/lifestyle intervention for the patient.Customer stated patient was to start physical therapy on (b)(6) 2024.No further details surrounding outcome of physical therapy, patient status, and patient outcome will be provided.

• Brand Name: BIOCORE
• Common Device Name: MINERAL COLLAGEN COMPOSITE BIOACTIVE MOLDABLE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 22162085
• Report Number: 2249852-2025-00014
• Device Sequence Number: 8920981
• Product Code: MQV
• UDI-Device Identifier: 00813954024769
• UDI-Public: (01)00813954024769(17)250630(10)FB220502
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K182074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: 06/30/2025
• Device Model Number: 214-0060-ST
• Device Catalogue Number: 214-0060-ST
• Device Lot Number: FB220502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown