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

Model Number	X022-0240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of product complaints on (b)(6) 2023.It was reported that a system pedicle screwdriver and torque handle were identified as broken and requested to be replaced.The complainant stated that they were informed, "the driver just fell apart after it was not working properly then the top came apart.", and the "torque handle had a driver stuck in it and as i was pulling it apart it broke." there were no known patient complications or delay in treatment associated with this complaint.Alternate available instruments were used to successfully complete the surgical procedure.A return authorization was issued for return of the complaint instruments, which as of (b)(6) 2023 have not been received at the manufacturer for complaint assessment.Additional attempts to gather relevant complaint incident information and confirm return of the complaint instruments were unsuccessful.
Additional Manufacturer Narrative
Visual and functional assessments of the complaint instruments could not be performed due to not being returned to the manufacturer for assessment.A dhr review could not be performed for the system pedicle screwdriver due to the lot number of instrument not being identified.A dhr review was performed for the system torque handle, and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution sine (b)(6) 2011.The failure mode of the instruments could not be confirmed, and the root cause of these complaints cannot be reliably determined due to a lack of available information.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor these instruments 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 lane; belgrade 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade
• MDR Report Key: 17750291
• Report Number: 3005031160-2023-00014
• Device Sequence Number: 12560972
• Product Code: HXX
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: X022-0240
• 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: 08/16/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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