MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number	X060-1520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 03/25/2025.It was reported that a system inserter was struck with a mallet during procedure, resulting in the proximal ratcheting arm to break off.There were no known patient complications or delay in treatment associated with this complaint.The physician was able to use an alternate instrument to successfully complete the procedure.The instrument was returned to the manufacturer and upon visual assessment, additional damage was identified at the distal tip of the system inserter/compressor.The complainant was unaware of the additional damage identified at the distal tip of the system inserter/compressor.No additional information available.
Additional Manufacturer Narrative
A visual assessment of the returned system inserter/compressor showed an instrument with repeated use, as identified by surface scratches.The compressor handle ratcheting arm and one stop on the distal tip of the instrument were fractured from the body of the system inserter/compressor.A functionality assessment was not performed due to the damaged condition of the returned system inserter/compressor, which was removed from distributable inventory.A dhr review was performed for the instrument 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 10/10/2024.It was reported that the system inserter/compressor was struck with a mallet, resulting in the breakage.The system inserter/compressor is intended to compress implants laterally after initial placement, and not intended to be impacted for implant placement.The complainant was unaware of the damaged distal tip and could not confirm when the damage occurred.The root cause of the ratcheting arm break is determined to be impacts to the system inserter/compressor which resulted in the observed instrument malfunction.The root cause of the broken distal tip is unable to be reliably determined, but could be related to the impacts to the system inserter/compressor.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• 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: 21892480
• Report Number: 3005031160-2025-00013
• Device Sequence Number: 8146868
• Product Code: PEK
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• 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): 04/23/2025

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: X060-1520
• Device Lot Number: SC2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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