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

Model Number	X060-0370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo of the instrument malfunction was provided, which showed one distal compressing arm of the instrument was fractured near the pivot point of the two instrument handles.A functionality assessment was not performed due to the complaint instrument not being returned to the manufacturer.If and/or when the complaint instrument is received, it will be final dispositioned and removed from distributable inventory.A dhr review was performed for the complaint instrument lot, 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 since 11/22/2011.The root cause of this complaint cannot be reliably determined.It may be possible that application of excessive compressing force may have contributed to the instrument malfunction.The two handles of the instrument have areas of reduced material to allow for the handles to connect at a pivot point with a lap joint.The instrument fracture location is where one handle transitions from full width to partial width for the lap joint.If excessive compressing force was applied to the instrument handles, it may be possible for the instrument to malfunction as observed.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.
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that a distal compressing arm of a system compressor malfunctioned while being used during a surgical procedure.There were no known patient complications associated with this complaint.An alternate available instrument was used to successfully complete the procedure.A return authorization was issued for return of the complaint instrument, which as of 12/07/2023 has not been received at the manufacturer for complaint assessment.

• 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: 18286706
• Report Number: 3005031160-2023-00023
• Device Sequence Number: 20500107
• Product Code: PEK
• UDI-Device Identifier: M697X06003701
• UDI-Public: M697X06003701
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: X060-0370
• Device Lot Number: 60173R
• 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: 11/07/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2011
• 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: 53 YR
• Patient Sex: Female