MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CALIX LUMBAR SPINAL IMPLANT SYSTEM; INSERTER

Model Number	X034-0015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a system complaint on 01/09/2026 in which it was reported that the distal tip of an inserter shaft broke from the device as it was being used to prep an implant for a lumbar fusion.The complainant stated that, "the surgical tech went to screw the inserter into the implant on the back table and the tip broke off in the implant, the tip was unscrewed out of the implant and a new inserter installed and implant was loaded onto new inserter and implanted with no issue.We removed the old inserter shaft and tip that broke off and its being sent back".There were no reported patient complications or delays in surgery.
Additional Manufacturer Narrative
Upon unaided visual inspection of the returned inserter shaft, it was confirmed that the distal threads had been sheared from the distal tip of the device.The sheared portion of the device was not level, indicating the possibility that the implant or inserter shifted while the threaded portion was engaged with the implant.The sheared distal threaded tip of the device showed signs of damage as identified by threads that appeared to have been smashed by a plier like device.It can be inferred that the threads of the inserter were damaged when the surgical tech removed the sheared distal tip from the implant.The shaft of the inserter showed signs of repeated use as identified by surface blemishes and impact marks on the handle of the device.The inserter housing appeared to be well used as identified by minor surface blemishes and scratches.The laser marking on the inserter housing was still present and legible.There were no visual signs of damage to the inserter housing.A functional test was not completed for the instrument due to the damaged condition of the device, which was removed from distributable inventory.A dhr review for lot 6005-01 showed that the inserter was manufactured to specifications prior to being released to distributable inventory.The device was released on 05/05/2016, giving it an approximate age of 9 years.The root cause of this complaint is that the shaft of the inserter was shifted while engaging with the implant, leading to the threaded end being broken from the shaft of the inserter.Additionally, repeated exposure to rotational forces and extreme temperature fluctuations from the sterilization cycles could have contributed to fatigue of the device components.There have been no other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for system inserters that are reported as having their distal tip sheared from the device and will perform complaint investigations as appropriate.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Common Device Name: INSERTER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln.; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln.; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 24251804
• Report Number: 3005031160-2026-00004
• Device Sequence Number: 8309167
• Product Code: HWA
• UDI-Device Identifier: M697X03400151
• UDI-Public: M697X03400151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: X034-0015
• Device Lot Number: 6005-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2016
• 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: 44 YR
• Patient Sex: Female