MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. COFIX POSTERIOR MIS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number	RAT20222
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection of the returned system inserter showed an instrument with repeated use, as identified by surface scratches, worn laser markings, and impact marks present.The ball handle assembly was separated from the body of the instrument as reported.The pin intended to connect the tube to the frame handle was not present and the weld that secures the tube to the frame handle had separated.Impact marks were identified on the frame frontside and frame backside.A functionality assessment was not performed due to the damaged condition of the returned system inserter.The instrument and reported malfunction were provided to the contract manufacturer on 2/27/2025 for further inspection and investigation.The investigation performed by the contract manufacturer included a dhr review, and an ncmr was identified and reported to have no influence on the observed instrument malfunction.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 9/03/2020.The components of the system inserter that separated were initially connected with a pin and weld.The returned system inserter weld was broken, and the pin was not present.Repeated use and impacts to the system inserter may have contributed to the instrument components breaking.It may be possible that repeated use and applied forces led to the observed instrument malfunction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of broken system inserters and perform complaint investigations.
Event or Problem Description
The manufacturer was made aware of a product complaint on 2/26/2025.It was reported that a system inserter was broken and requested to be replaced.There were no known patient complications or delay in treatment associated with this complaint.The physician was able to use the complaint instrument to successfully complete the procedure.A return authorization number was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 3/03/2025.

• Brand Name: COFIX POSTERIOR MIS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• 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 lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 21678617
• Report Number: 3005031160-2025-00008
• Device Sequence Number: 15395610
• Product Code: PEK
• UDI-Device Identifier: 04260636670459
• UDI-Public: 04260636670459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201704
• 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 Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: RAT20222
• Device Lot Number: PSC2032017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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 Age: 67 YR
• Patient Sex: Female