MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	X066-161307L-PC
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 7/17/2025.It was reported that after placing a system interbody spacer the locking arm of the implant would not capture and retain the implant screw as intended.The interbody was removed and replaced with an alternate implant, which allowed for the implant screw to lock into the spacer as intended.There was no known patient complications associated with this complaint.A return authorization number was issued for return of the complaint implant and screws, which arrived at the manufacturer for assessment on 7/30/2025.
Additional Manufacturer Narrative
A visual assessment of the returned interbody spacer and associated screws showed normal signs of being implanted and explanted.The plasma coating on one side of the interbody spacer was damaged, presumably from implantation and explantation.The interbody spacer faceplate component of the implant had remnants of one locking arm present, which was bent towards the middle of the implant.Damage was identified on the hole of the faceplate where the locking arm was broken.The implant screw returned was damaged at the head, collar, and threading as well as the anodization was worn off from contact.A dhr review was performed for complaint implant lot and there was no manufacturing deficiencies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 9/12/2024.The interbody spacer includes two locking arms that are intended to engage and capture the implant screw, preventing it from migrating.If the implant screw was not placed appropriately, it may be possible that the locking arm of the interbody spacer would not engage and capture the implant screw as intended.The system surgical technique guide provides guidance on appropriate interbody spacer placement and fixation with system screws.The screw hole preparation section of the stg states, "angulating the awl greater than 3 degrees in any direction from the prescribed angle may result in driving a screw in a direction that prevents the locking arm from engaging and capturing the screw." there have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of implants that are explanted and replaced and will perform complaint investigations and regulatory reporting as appropriate.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 22738799
• Report Number: 3005031160-2025-00026
• Device Sequence Number: 7198350
• Product Code: OVE
• UDI-Device Identifier: M697X066161307LPC1
• UDI-Public: M697X066161307LPC1
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K162944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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 Model Number: X066-161307L-PC
• Device Lot Number: 091272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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
• Patient Sex: Unknown