MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X022-0240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned pedicle screwdriver showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal threads of a sub-assembly component were fractured with a pedicle screw stuck on the driver as reported.The attached pedicle screw was damaged on the tulip in a manner that suggests a tool was used in an attempt to disengage from the driver.A functionality assessment was not performed due to the damaged condition of the complaint instrument, which was removed from distributable inventory.A dhr review was performed for lot# 5911-01 and there were no manufacturing deficiencies identified.The instrument lot met all required specifications prior to being released to distributable inventory.The instrument lot has been available for distribution since 6/17/2016.It was reported that the system pedicle screwdriver would not effectively engage a pedicle screw and was assessed as a wobbly connection due to damaged distal threading.The system pedicle screwdriver may not effectively engage with a pedicle screw if the distal threading of the screwdriver is damaged.The distal threading of the system pedicle screwdriver engages with the internal threading of the pedicle screw.If the threading of the system pedicle screwdriver was damaged, it would prevent effective engagement with the pedicle screw.It may be possible to damage the distal threading of a system pedicle screwdriver if the attached ratcheting handle was not in the neutral non-ratchetting position.The system surgical technique guide provides guidance on loading pedicle screws onto the pedicle screwdriver and highlights the importance of the ratcheting handle being in the neutral non-ratcheting position.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor reports of instrument malfunctions and perform complaint investigations and regulatory reporting as appropriate.
Event or Problem Description
The manufacturer was made aware of an instrument malfunction on (b)(6) 2026.It was reported that the distal threading of a pedicle screwdriver assembly was damaged, which resulted in a system screw being stuck on the driver.There were no known patient complications or delays in treatment associated with this complaint.An alternative available instrument was used to successfully complete the surgical procedure.A replacement instrument was provided, and an rma# was issued for return of the complaint instrument, which was received at the manufacturer for assessment on (b)(6) 2026.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL 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: 24984024
• Report Number: 3005031160-2026-00013
• Device Sequence Number: 9642434
• Product Code: MNI
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: X022-0240
• Device Lot Number: 5911-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2016
• 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