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

Model Number	214-0120-ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Back pain (4895)
Date of Event	04/16/2025
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.Biocore moldable bioactive graft was used in a patient for posterolateral spine surgery on (b)(6) 2024.The graft was placed in vertebrae locations 3-4, 4-5 and 5-s1 and mixed with bone marrow aspirate and autograft (not collagen matrix, inc.Products).A cage and invictus screws (not collagen matrix, inc.Products) were also used in conjunction with the biocore product during the initial surgery.Customer stated the biocore product handled and performed excellent, and there were no notable complications observed during implantation.At a routine 6-week follow-up visit on (b)(6) 2024, the patient reported no pain in their back or legs.The spinal fusion based off radiograph was classified as satisfactory.No other concomitant medical treatments were noted and there were no complications or adverse events reported at this follow-up visit.At a routine 3-month follow-up visit on (b)(6) 2025, patient reported pain in the lower back but no pain in either leg.The spinal fusion assessment based on radiograph maintained a satisfactory level.It was noted there was complete resolution of knee pain at this time.Patient had a steroid injection at the 3-month follow-up as well.Patient returned on (b)(6) 2025 in which the adverse event was reported.The patient was diagnosed with sacroiliitis in the lower back and left leg, in which the return of radicular symptoms was noted, with an adverse event onset date of (b)(6) 2025.This was classified as an unexpected, but not severe, adverse event.Intervention included left sacroiliac joint injection of celestone and marcaine performed on (b)(6) 2025.Medications were also prescribed (flexeril 5mg, ibuprofen 800mg and medrol dosepak).Prior to the (b)(6) 2025 visit, a ct of the lumbar scan was taken ((b)(6) 2025) and an mr of the lumbar spine was taken ((b)(6) 2025).No further details surrounding the patient status, patient outcome, or event 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
• 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: 22532890
• Report Number: 2249852-2025-00033
• Device Sequence Number: 7425328
• Product Code: MQV
• UDI-Device Identifier: 00813954024776
• UDI-Public: (01)00813954024776(17)270531(10)FB240501
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: 214-0120-ST
• Device Catalogue Number: 214-0120-ST
• Device Lot Number: FB240501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female