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 Code	Pain (1994)
Date of Event	05/30/2024
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 reported to be diagnosed with lumbar spondylosis with radiculopathy.The biocore mineral collagen composite bioactive moldable product was used on a patient during posterolatoeral spinal surgery on (b)(6) 2024.Product was implanted in vertebrae location 3-4 and 4-5.The biocore product was mixed with bone marrow aspirate and autograft (not collagen matrix, inc.Products).Atec invictus modular screws were also used during this procedure (not manufactured or distributed by collagen matrix, inc.).Customer reported there were no complications noted during product implant and the prdouct handled and performed excellent.On 05/30/2024, it was reported patient exhibited left shoulder impingement syndrome, where the patient reported left should pain localized in the left shoulder blade region.Customer stated this was not an unexpecteed adverse event nor was it a serious adverse event.The patient had an "ortho consult" followed by an intervention method of physical therapy.Patient participated in physical therapy to treat the reported adverse event.Customer noted the adverse event stop date was (b)(6) 2025, and the reported event was not related to the intervention (physical therapy) required.No further details surrounding outcome of physical therapy, patient status, or 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
• 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: 22162449
• Report Number: 2249852-2025-00016
• Device Sequence Number: 7369399
• Product Code: MQV
• UDI-Device Identifier: 00813954024776
• UDI-Public: (01)00813954024776(17)260228(10)FB221001
• 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
• Report Source: Other
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/28/2026
• Device Model Number: 214-0120-ST
• Device Catalogue Number: 214-0120-ST
• Device Lot Number: FB221001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female