MAUDE Adverse Event Report: Xtant Medical Holdings, Inc. Cortera Spinal Fixation System; Thoracolumbosacral Pedicle Screw System

Model Number	150103-65045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction

• Brand Name: Cortera Spinal Fixation System
• 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 ; +1(406)924-5878
• MDR Report Key: 50213525
• Report Number: 3005031160-2026-00031
• Device Sequence Number: 6122316
• Product Code: NKB
• UDI-Device Identifier: 00810076568485
• UDI-Public: 00810076568485
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: AP23000083
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown