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	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant stated that the surgeon, "was attempting to place a (system) implant into a very tight intervertebral space.As dr.Was turning the implant for optimal position and striking the inserter forcefully with a mallet, the distal tip of the inner inserter shaft broke off, at the interface/threads.Oddly, this happened twice during the surgery." a visual assessment of the returned inserters showed well used instruments as identified by minor surface scratches and blemishes.It was also confirmed that the distal threaded tips had been fractured from the inner shaft of the devices.The outer housing of the inserters remained intact and undamaged.The ball end of the inserters had visible impact marks, indicating that they had been repeatedly struck throughout their lifetime.A functional assessment was not completed due to the damaged condition of the returned inserters.A dhr review was performed for lot# 6005-01 and no manufacturing anomalies were identified.The system inserters met specifications prior to being released to distributable inventory.Lot #6005-01 has been available for distribution since 05/05/16.There has been one other complaint 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 tips broken from the inner shaft of the instruments and will perform complaint investigations and reporting as appropriate.
Event or Problem Description
The manufacturer was contacted on 03/02/2026 to report an issue with two system inserters.It was reported that the distal threaded tips of the inner shafts of the inserters were fractured from the instruments while they were being used to place implants during a l3-s1 tlif.This incident occurred with two different inserters on two separate implants.The fractured tips of the inserters were not recoverable as they remained embedded in the implants, which were successfully implanted with the inserters despite the reported issues.A return authorization number was issued for the return of the complaint instruments, which were received at the manufacturer for assessment on 03/12/2026.Report 1 of 2.

• Brand Name: CALIX LUMBAR SPINAL IMPLANT SYSTEM
• Common Device Name: INSERTER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 644 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 24698161
• Report Number: 3005031160-2026-00011
• Device Sequence Number: 10176886
• Product Code: HWA
• UDI-Device Identifier: M697X03400151
• UDI-Public: M697X03400151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/26/2026

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: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/26/2026
• 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 Sex: Unknown