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

Model Number	05-EXT-REM-PLIER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
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 the spring broken on removal pliers during a posterolateral fusion revision 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.
Additional Manufacturer Narrative
A visual assessment of the returned system removal pliers showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The interior spring on the handle of the instrument was broken 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 # 259179-c 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) 2016, resulting in a lifespan of 9 years.The root cause of the broken spring of the plier could not be reliably determined; however, it may be possible for the interior spring to be broken if excessive force was applied.There has not been a 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.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: 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: 23295299
• Report Number: 3005031160-2025-00036
• Device Sequence Number: 11977414
• Product Code: NKB
• UDI-Device Identifier: 00846468050641
• UDI-Public: 00846468050641
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 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: 05-EXT-REM-PLIER
• Device Lot Number: 259179-C
• 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: 12/01/2016
• 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