MAUDE Adverse Event Report: XTANT MEDICAL 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	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system implant plate is secured to the inserter/compressor by tightening a set screw on the instrument.It may be possible to fracture the distal tip of an inserter/compressor if excessive force was applied to the interface between the inserter/compressor and implant plate by over tightening the set screw.The root cause of this complaint cannot be reliably determined due to a lack of available information.The complaint investigation suggests the possibility that the set screw that secures the implant plate to the inserter/compressor was over tightened, resulting in the distal portion of the instrument breaking.
Event or Problem Description
The company received notification on (b)(6) 2021 of a system inserter/compressor that was reported to malfunction when loading an implant onto the instrument.Five attempts to gather relevant complaint incident information and request the instrument to be returned were made, and no additional information was provided.There were no known patient complications reported as part of this instrument complaint.The instrument 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; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12510841
• Report Number: 3005031160-2021-00018
• Device Sequence Number: 3289165
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other