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

Model Number	725-163
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system driver showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal tip of the driver was fractured as reported and not present.A functionality assessment was not performed due to the damaged condition of the returned driver, which was removed from distributable inventory.A dhr review for lot# 377585 was performed 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 9/15/2020.The system driver was requested to be replaced because it was not in condition to function as intended.It was reported that the distal tip of the driver was broken during a scheduled removal/revision procedure.The complainant stated the instrument was being used in a manner that the instrument was not designed for, resulting in the observed instrument malfunction.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of instrument malfunctions 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 distal tip of a system driver was broken during a surgical procedure on (b)(6) 2025.There was no known patient complications associated with this instrument complaint, the procedure was successfully completed without any known issue.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for complaint assessment on (b)(6) 2025.

• Brand Name: STREAMLINE MIS SPINAL FIXATION 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: 23077883
• Report Number: 3005031160-2025-00032
• Device Sequence Number: 10064311
• Product Code: NKB
• UDI-Device Identifier: 00191083014616
• UDI-Public: 00191083014616
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 725-163
• Device Lot Number: 377585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male