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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned inserter/compressor showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal tip on one side of the returned inserter/compressor was broken where a pin secures it to the main body of the inserter/compressor.A functionality assessment was not performed due to the damaged condition of the returned inserter/compressor which was removed from distributable inventory.A dhr review was performed for the returned inserter/compressor lot and there were 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 2/10/2021.The distal tip of the system inserter/compressor is attached to the instrument body with a pin that allows for minor movement of the tip for implant placement in various patient anatomy.It may be possible for the distal tip of the system inserter/compressor to fracture if excessive compression force was applied to the instrument.There has been one other complaint for the distal tip of the system inserter/compressor breaking in the past 12 months.The manufacturer will continue to monitor the field for complaints of similar nature.
Event or Problem Description
The manufacturer was made aware of a product complaint on 3/01/2024.It was reported that a system inserter/compressor was broken during a surgical procedure.There were no known patient complications or delay in treatment associated with this complaint.The system implant was successfully placed with the complaint inserter/compressor.An rma# was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 3/07/2024.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• 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
• MDR Report Key: 18969083
• Report Number: 3005031160-2024-00006
• Device Sequence Number: 6154867
• Product Code: HTC
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: 21179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male