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

Model Number	02-FINALDRIVER
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 12/03/2025.It was reported that two system drivers were damaged during surgery.There were no reported patient complications or delay in surgery associated with this complaint.The instruments were not returned to the manufacturer, and no additional information was provided by the complainant after multiple requests for information.Report 1 of 2.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the complainant.No device was returned for evaluation; further no photographs were provided.Operative notes and/or medical records were not provided for review of usage/technique.The damage to the instrument was not able to be identified due to limited information from the complainant.The manufacturer received no additional information after repeated follow ups with the complainant.A review of manufacturing records was unable to be completed as the lot information of the product was not available.No further investigation was able to be performed at this time.A root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.There have been zero other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of damaged system drivers and perform complaint investigations as appropriate.
Event or Problem Description
A follow-up report to 3005031160-2025-00045 submitted on 12/31/2025 is being submitted as additional information is available and the manufacturer has completed investigation activities.
Additional Manufacturer Narrative
The manufacturer was made aware of product complaint on 12/03/2025.It was originally reported that two screwdrivers of different systems broken during a procedure.The complainant provided additional information clarifying that three screwdrivers of the same system broke when attempting to remove set screws.There were no patient complications or delay in procedure.The procedure was able to be successfully finished with alternate instruments.The complaint instruments were not returned to the manufacturer for assessment.A dhr review was performed for lot # 417253 and no manufacturing anomalies were identified.The system screwdriver lot met specifications prior to being released to distributable inventory.(b)(4).A definitive root cause was unable to be determined with the information provided; however, the screwdriver damage may be related to excessive force applied to the instrument.This report is being submitted to relay additional information.The following fields were updated: b3, d4, e1, g6, h4, h6.Follow up report 3 of 3.
Additional Manufacturer Narrative
The manufacturer was made aware of product complaint on (b)(6) 2025.It was originally reported that two screwdrivers of different systems broken during a procedure.The complainant provided additional information clarifying that three screwdrivers of the same system broke when attempting to remove set screws.There were no patient complications or delay in procedure.The procedure was able to be successfully finished with alternate instruments.The complaint instruments were not returned to the manufacturer for assessment.A dhr review was performed for lot #417253 and no manufacturing anomalies were identified.The system screwdriver lot met specifications prior to being released to distributable inventory.Lot #417253 has been available for distribution since (b)(6) 2022.A definitive root cause was unable to be determined with the information provided; however, the screwdriver damage may be related to excessive force applied to the instrument in attempt to remove instrumentation.This report is being submitted to relay additional information.The following fields were updated: b3, d4, e1, g6, h4, h6.Follow up report 1 of 3.
Event or Problem Description
A follow-up report to 3005031160-2025-00045 submitted on (b)(6) 2025 is being submitted as additional information is available and the manufacturer has completed investigation activitites.

• 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: 23936490
• Report Number: 3005031160-2025-00045
• Device Sequence Number: 13164613
• 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,Followup,Followup
• Report Date (Section B): 02/06/2026

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: 02-FINALDRIVER
• Device Lot Number: 417253
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/08/2026; Not provided
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/06/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• 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