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

Model Number	T066-0162
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned trial showed an instrument with repeated use, as identified by minor cosmetic blemishes and worn, but legible laser markings.As reported, the distal tip of the 8mm side of the trial had been fractured from the handle of the device.The central shaft of the handle still had its distal connection pin/tab in place, however, the surrounding weld had been fractured, causing the 8mm trial head dissociate from the handle.A functionality assessment was not performed due to the damaged condition of the returned trial.A dhr review was performed for the instrument lot and there was no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 03/08/2014.The root cause of this complaint is that the weld holding the 8mm side of the trial failed while the trial was in use, resulting in the dissociation of the trial end from the handle.There have been no other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for trials that do not function as intended and will facilitate/perform complaint investigations as needed.
Event or Problem Description
It was reported that a 7/8mm trial failed during surgery.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: TRIAL
• 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: 21942442
• Report Number: 3005031160-2025-00016
• Device Sequence Number: 18279682
• Product Code: OVE
• UDI-Device Identifier: M697T06601621
• UDI-Public: M697T06601621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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
• Device Model Number: T066-0162
• Device Lot Number: 022781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown