MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CORTERA SPINAL FIXATION SYSTEM; TORQUE LIMITING HANDLE

Model Number	1505-000120
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received information from a distributor regarding a potential concern associated with a thoracolumbar system.The report consisted of a single x-ray image transmitted via text message.The distributor indicated that the image was believed to be associated with the manufacturer's instrumentation; however, no case-specific details, including patient information, procedural information, implant details, or clinical outcomes, were provided.The image was internally forwarded for clinical review.The distributor declined to provide any additional information regarding the circumstances surrounding the image, including whether a revision procedure had occurred.As a precautionary measure, two torque-limiting handles within the distributor's inventory were proactively exchanged and returned to the manufacturer for evaluation.Functional testing of the returned torque-limiting handles demonstrated that both devices met established performance specifications and were operating as intended.The evaluation results were communicated to the distributor, who acknowledged receipt.No further information, including additional imaging, clinical documentation, product samples, or device identifiers, has been provided to support further investigation.At this time, there is insufficient information to establish a causal relationship between the reported image and the manufacturer's system, or to confirm whether a device malfunction or adverse event occurred.No additional complaints or similar events have been reported in association with this matter.The manufacturer will continue to monitor for any new or relevant information.Should additional details become available, the complaint will be reassessed in accordance with internal procedures and regulatory requirements.
Event or Problem Description
The manufacturer was made aware of two 90 in-lb torque-limiting handles that were requested to be replaced and verified for torque-limiting calibration.The returned torque limiting handles were tested and were found to be within specification.Additionally, an x-ray image was provided with the complaint; however, no context was provided with the image and there was no identifying information linking the image to the torque-limiting handles.There were no reported patient injuries or delays in surgery associated with the complaint.

• Brand Name: CORTERA SPINAL FIXATION SYSTEM
• Common Device Name: TORQUE LIMITING HANDLE
• 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: 25393493
• Report Number: 3005031160-2026-00018
• Device Sequence Number: 20131556
• Product Code: LXH
• UDI-Device Identifier: 00840311210756
• UDI-Public: 00840311210756
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K241892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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
• Device Model Number: 1505-000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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