MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. IRIX-A LUMBAR INTEGRATED FUSION SYSTEM; RONGEUR

Model Number	T080-0100-10
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received a complaint from a representative regarding an event involving a 6 mm anterior kerrison rongeur during a surgical procedure.It was reported that approximately six months prior to the manufacturer becoming aware of the event, a 6 mm anterior kerrison rongeur malfunctioned during use.Specifically, the instrument was reportedly used to leverage open the disc space, and during rotation, the instrument disengaged.No patient injury or adverse health consequences were reported.The subject device was not returned for evaluation; therefore, a root cause could not be determined.A review of the device history records and manufacturing documentation could not be performed, as no lot or identifying information was provided.Based on the information available, the reported use of the device appears to be inconsistent with its intended use.Kerrison rongeurs are intended for cutting tissue and are not designed to be used for levering or prying open disc space.There have been no other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for 6 mm anterior kerrison rongeurs that are reported as broken and will perform complaint investigations and reporting as appropriate.
Event or Problem Description
The manufacturer received a complaint from a distributor on (b)(6) 2026 reporting that a 6 mm anterior kerrison rongeur reportedly disengaged during use.The complainant indicated the instrument was being used to leverage open the disc space, and during rotation, the instrument reportedly disengaged.The event was reported to have occurred more than six months prior to notification; therefore, specific details regarding the timing and circumstances of the event are limited.No patient injury, adverse event, or delay in the surgical procedure was reported.The manufacturer issued an rma for return of the complaint device; however, as of (b)(6) 2026, the device has not been returned and evaluation could not be performed.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Common Device Name: RONGEUR
• 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: 25458035
• Report Number: 3005031160-2026-00019
• Device Sequence Number: 21013979
• Product Code: HTX
• UDI-Device Identifier: M697T0800100101
• UDI-Public: M697T0800100101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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 Model Number: T080-0100-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown