MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CORTERA; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	150103-65045
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system screw showed a screw with use as identified by surface scratches on the head of the screw shank and initial threads and worn laser markings.The proximal end of the screw was dissociated as reported.A dhr review was performed for the screw lot which met all required specification prior to being released to distributable inventory.It has been available for distribution since on (b)(6) 2025.The root cause of the system screw implant malfunction has not yet been determined as the screw is being investigated by the engineering department.A follow up report will be submitted with the investigation results as they become available.There have been no other complaints of similar nature for this screw in the past 12 months.The manufacturer will continue to monitor the field for complaints of system screws that have the tulip dissociate from the screw shaft.
Event or Problem Description
It was reported that the patient underwent a l2-s1 revision lumbar fusion on (b)(6) 2026.During the procedure, the tulip/tower of a screw dissociated from the screw shaft during insertion of the screw.The screw shaft was removed, and a new screw was inserted without further issue and no noted delay in surgery.There were no known patient complications associated with this complaint.No additional information is available.
Additional Manufacturer Narrative
A failure analysis was completed by the manufacturer's engineering department on 02/25/2026 and all assembly components were confirmed to be present.It has been determined that the failure was likely due to user error during clinical steps.The root cause of the damaged set screw was determined to be excessive downward force applied on the tulip component causing the shank to press the saddle proximally past the swage geometry.
Event or Problem Description
A follow-up report to 3005031160-2026-00005 submitted on 02/18/2026 is being submitted as the manufacturer has completed investigation activities.

• Brand Name: CORTERA
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 24378482
• Report Number: 3005031160-2026-00005
• Device Sequence Number: 17359199
• Product Code: NKB
• UDI-Device Identifier: 00810076568485
• UDI-Public: 00810076568485
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K241892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 03/12/2026

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: 150103-65045
• Device Lot Number: AP24000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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