MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. NANOSS; BONE VOID FILLER

Model Number	90-100-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of two synthetic grafts from the same lot that were utilized on separate patients beyond the expiration date identified on the product packaging on 04/29/2026.The issue was identified via a product usage form that was submitted to the manufacturer, which identified two 1cc synthetic grafts that had surpassed the labeled expiration date.The grafts had a documented expiration date of 04/09/2026 and were implanted on (b)(6) 2026.The distributor representative listed on the charge sheet was notified of the complaint and confirmed that there were no reported delays in surgery and no known patient complications associated with the use of the expired grafts.The complaint grafts were not returned as they remain implanted in the patients.Report 1 of 2.
Additional Manufacturer Narrative
The grafts within the scope of this complaint were not available for visual inspection, as they were implanted in the patients.A review of the production records for lot number 456617 was conducted, and no manufacturing or production deficiencies were identified.The grafts met all required specifications prior to release to distributable inventory.It was reported that the grafts, which expired on 04/09/2026, were implanted on (b)(6)2026.The manufacturer distributed the grafts on 03/06/2026, which was 34 days prior to the expiration date.The recipient was informed of the expiration date prior to distribution via verbal communication and through the packing slip provided at the time of shipment.The grafts were also clearly labeled with the correct expiration date.Additionally, on 04/23/2026, the manufacturer notified the recipient via email that they were in possession of expired or expiring grafts, which was six days prior to implantation.Based on the investigation, the root cause of this complaint was the use of grafts beyond their labeled expiration date at the point of care, despite multiple notifications and clear expiration labeling provided to the consignee by the manufacturer.There have been no other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor reports of grafts being implanted past their expiration date and will continue to perform complaint investigations and regulatory reporting as appropriate.

• Brand Name: NANOSS
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln.; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln.; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln.; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 25300780
• Report Number: 3005031160-2026-00015
• Device Sequence Number: 21187858
• Product Code: MQV
• UDI-Device Identifier: 00849777012393
• UDI-Public: 00849777012393
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K132050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2026
• Device Model Number: 90-100-01
• Device Lot Number: 456617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male