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

Model Number	214-0120-ST
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Weight Changes (2607)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint submitted through clinical data collection.Limited information provided and it is unlikely additional information will be provided.Two biocore products (different item numbers and different lot numbers) were used on a patient for posterolatoeral spinal surgery on (b)(6) 2025.Biocore products were implanted in locations l3-l4 and l4-l5 of the vertebrae and mixed with bone marrow aspirate and autograft (not collagen matrix, inc.Products).Rods, invictus screws, and two cages were also used (not collagen matrix, inc.Products).Customer confirmed there were no complications noted during implantation and the biocore products handled excellent.At a 6-week follow-up appointment on (b)(6) 2025, an adverse event of systemic weight loss was reported, in which the had a loss of appetite after surgery with subsequent weight loss of 28 pounds in 6 weeks.The patient was referred for a gastro enterologist consultation.The following intervention types were noted: add protein shakes to their diet, keep a calorie count, and possible therapy sessions.No further details surrounding patient outcome or patient status will be provided.
Additional Manufacturer Narrative
This is for suspect device 1 and is the parent mdr.Refer to mdr 2249852-2025-00030 for suspect device 2.

• Brand Name: BIOCORE
• Common Device Name: MINERAL COLLAGEN COMPOSITE BIOACTIVE
• 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: 22418876
• Report Number: 2249852-2025-00029
• Device Sequence Number: 7100574
• Product Code: MQV
• UDI-Device Identifier: 00813954024776
• UDI-Public: (01)00813954024776(17)260430(10)FB221003
• 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: 2025
• 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): 07/07/2025

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: 04/30/2026
• Device Model Number: 214-0120-ST
• Device Catalogue Number: 214-0120-ST
• Device Lot Number: FB221003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male