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

Model Number	05-FINALDRIVER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2025.It was reported that final tightening a system screw during a lumbar fusion procedure, the distal tip of a system screwdriver was broken and requested to be replaced.There was a minimal delay in treatment and no known patient complications associated with this complaint.An alternate available instrument was used to successfully complete the procedure.A return authorization number was issued for the return of the complaint instrument, which was received at the manufacturer for assessment on (b)(6) 2025.
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by surface scratches and worn laser marking.The distal tip of the instrument was fractured and 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 the lot 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 06/03/2020.The torque limiting handle that was connected to the driver when the malfunction occurred was returned with the driver.After assessment and testing of the torque limiting handle, it was found to be not limiting torque as intended (should limit applied torque at 80 in/bs, and consistently tested over the limit at 107, 124, 120, 117 in/lb).The root cause of the broken distal tip was determined to be excessive rotational force due to utilization of the out of calibration torque limiting handle.It may also be possible for the distal tip of the screwdriver to be broken if the screwdriver was shifted out of alignment while engaged with a system implant screw.There have been two other complaints 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.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 22534945
• Report Number: 3005031160-2025-00023
• Device Sequence Number: 15309807
• Product Code: NKB
• UDI-Device Identifier: 00846468050658
• UDI-Public: 00846468050658
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192396
• 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): 07/17/2025

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: 05-FINALDRIVER
• Device Lot Number: 364246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2020
• 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