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

Model Number	X060-1520
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functionality assessments were not performed due to the complaint instrument not being received for complaint assessment.A dhr review could not be performed due to the lot number of the complaint instrument not being identified.If the complaint instrument is received at the manufacturer, it will be assessed and a follow up report will be submitted if appropriate.
Event or Problem Description
The manufacturer received notification on 6/21/2022 of a system inserter/compressor that malfunctioned during a surgical procedure.It was reported that one of the distal tips of the instrument fractured while compressing interspinous plates into place and securing the plates.There were no known patient complications associated with this complaint.The procedure was successfully completed with an alternate available instrument.

• 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: 15048096
• Report Number: 3005031160-2022-00022
• Device Sequence Number: 17515191
• Product Code: PEK
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/18/2022

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
• 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: 06/21/2022
• Initial Report FDA Received Date: 07/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male