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	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system inserter/compressor showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal lip of the instrument was fractured and not present.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for the instrument lot which met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 6/14/2019.It may be possible for the observed instrument malfunction to occur if excessive force was placed on the set screw that engages and retains the system implant to the inserter/compressor.The set screw that engages and retains the system implant is intended to be tightened to securely retain the implant.If force is applied beyond what is required to securely retain the implant, it may result in the distal lip of the instrument to malfunction as observed.Based on the information reviewed, the root cause of this event was determined to be an unintended user error related to excessive force placed on the set screw that engages and retains the system implant.There has been one other complaint of similar nature for this instrument in the past 12 months.The manufacturer will continue to monitor the field for complaints of system inserter/compressors with broken distal lips.
Event or Problem Description
It was reported that the distal implant grasping portion of a system inserter/compressor was broken while engaging a system implant.There were no known patient complications or delay in treatment associated with this complaint.A return authorization number was issued for return of the complaint instrument, which was received at the manufacturer for assessment.

• 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 MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 19354731
• Report Number: 3005031160-2024-00011
• Device Sequence Number: 7678047
• Product Code: PEK
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• 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): 05/20/2024

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: 14652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2019
• 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: Prefer Not To Disclose