MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. MINEROSS XP; PORCINE ANORGANIC BONE MINERAL

Model Number	MINXP-CAN0.5SM
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Collagen matrix, inc.Received medwatch form mw5166536-1 from the fda on 02/17/2025.The form indicates that on (b)(6) 2024, the patient had an allograft done at an unknown site/location.Since then, the patient contracted tuberculosis (tb) and has been working with physicians to get on a 9-month antibiotic regimen.Since the last time the patient tested negative for tb.The only other person the patient had substantial contact with has recently tested negative for tb.As a result, it is suspected that the allograft to be the means by which the patient contracted tb.In the initial medwatch form, the following products were indicated as follows: information about the companies involved in providing the bone tissue used in (b)(6) allograft: mineross xp, ref: minxpcan0.5sm lot pmcu23k1; use by 2026-08-31 manufacturer: collagen matrix inc.Distributed by (b)(4) lot: fg24030528, cortical and cancellous chips 1.0cc quality department (b)(6).Cadaver bone tissue implanted in allograft.Collagen matrix, inc.Reached out to the initial complainant that our product is a xenograft (porcine anorganic bone mineral) and not an allograft initially indicated in the medwatch form.Additional information received on 03/10/2025 by the initial complainant "our oral surgeon said that the patient did in fact receive her allograft from human tissue, not porcine as you claim.Additional information was received on 03/19/2025 after a meeting with the clinician, it was confirmed that mineross xp manufactured by collagen matrix, inc.Was not used in the patient's procedure.The product used was genate blend cortical & cancellous chips (1.0cc), distributed by biohorizons, and listed under the reference min-c1.0 with lot number fg24030528, expiration date: 02/28/2029.The procedure involved the extraction of tooth #3 on (b)(6) 2024, followed by grafting at the same site on (b)(6) 2024.A follow-up appointment took place on (b)(6) 2024, with an updated ct scan on (b)(6) 2024.The patient tested positive for tb on (b)(6) 2025, several months after the surgery.It was noted that the patient had no symptoms and undergoes yearly tests for viral load, which inadvertently led to the positive tb test.The patient did not travel outside of the us within the year of a diagnosis.Qa assessment determined that the dhr met release criteria.Qc testing from the dhr met acceptance criteria.Product meets regulatory requirements.

• Brand Name: MINEROSS XP
• Common Device Name: PORCINE ANORGANIC BONE MINERAL
• 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 ; 2014051477
• MDR Report Key: 21677347
• Report Number: 2249852-2025-00002
• Device Sequence Number: 7740363
• Product Code: NPM
• UDI-Device Identifier: 00813954021645
• UDI-Public: (01)00813954021645(17)260831(10)PMCU23K1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/24/2025

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: 08/31/2026
• Device Model Number: MINXP-CAN0.5SM
• Device Lot Number: PMCU23K1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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 Sex: Unknown