MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. STREAMLINE TL SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	02-FINALDRIVER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system final driver showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal tip of the instrument was not present as reported.A functionality assessment was not performed due to the damaged condition of the returned driver, which was removed from distributable inventory.A dhr review was performed for lot # 067339 and there was no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since (b)(6) 2010, resulting in a lifespan of 15 years.The root cause of the broken distal tip could not be reliably determined, however, it may be possible for the distal tip of the screwdriver to be broken if excessive rotational force was applied, or if the screwdriver was shifted out of alignment while engaged with a system implant screw.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of malfunctioned system instruments and perform complaint investigations as appropriate.
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2025.It was reported that the tip of a final driver was damaged when removing screws during a lumbar fusion procedure performed on (b)(6) 2025.An alternative instrument was available to successfully complete the surgery.There was no delay in surgery and no known patient complications.A return authorization was issued for the return of the complaint driver, which was received by the manufacturer on (b)(6) 2025.

• Brand Name: STREAMLINE TL 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 ; 4069245878
• MDR Report Key: 23295276
• Report Number: 3005031160-2025-00035
• Device Sequence Number: 9952856
• Product Code: NKB
• UDI-Device Identifier: 00846468006198
• UDI-Public: 00846468006198
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192800
• 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): 10/14/2025

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: 02-FINALDRIVER
• Device Lot Number: 067339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2010
• 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