MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. FORTILINK-TS IBF SYSTEM; INSERTER

Model Number	65-TS-INSERTER
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments were unable to be performed due to the instrument not being returned to the manufacturer.A photograph was provided by the complainant, however, the reported damage and identifying markings were not able to be identified in the image.No additional details were provided by the complainant in regard to the condition of the device and its failure mode.A review on the device manufacturing records was not completed because the complainant did not provide a lot number and it was not visible in the image provided by the complainant.A definitive root cause could not be determined because the instrument was not returned for assessment, and no additional identifiers were provided.There have been three other complaints of similar nature in the past twelve months.The manufacturer will continue to monitor for reports of damaged system inserters and will perform complaint investigations and regulatory reporting as necessary.
Event or Problem Description
The complainant contacted the manufacturer on 10/21/2025 to report a product complaint with a system inserter.It was reported that the inserter broke during surgery and was requested to be replaced.No other complaint details were provided by the complainant.

• Brand Name: FORTILINK-TS IBF 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.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln.; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 23582073
• Report Number: 3005031160-2025-00038
• Device Sequence Number: 21215643
• Product Code: ODP
• UDI-Device Identifier: 00846468084417
• UDI-Public: 00846468084417
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K213493
• 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): 11/18/2025

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
• Device Model Number: 65-TS-INSERTER
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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