MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CERVALIGN; ANTERIOR CERVICAL PLATE SYSTEM

Model Number	66-VST-40-16
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photograph imaging was provided of the placed system plate and metal shavings identified, as well as lateral x-ray imaging of the implant construct.The xray imaging showed the system plate was implanted with an unknown interbody spacer.The inferior screws of the system plate appeared to be at a length where they extend beyond the interbody fixation blades, resulting in an area where the screws may contact the interbody fixation blades and it is possible this unintended contact may have contributed to the observed metal shavings.The ifu for this system states "preoperative planning and patient anatomy should be considered when selecting cervical screw diameter and length".A dhr review was performed for lot # 351105 and there was no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/06/2019, resulting in a lifespan of approximately 6 years.Communication with the complainant confirmed there was no extreme angulation of the screws, which could result in a higher likelihood of blade contact as they would follow normal trajectory and be directed more medial.The root cause of this complaint cannot be reliably determined, although the complaint investigation suggests the possibility that contact of the interbody fixation blades and the system implant screws may have resulted in the observed metal shavings.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of malfunctioned system screws.
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2025.It was reported that during an anterior cervical discectomy and fusion procedure performed on (b)(6) 2025, the surgeon noticed metal shavings upon screw insertion.There were no patient complications or delay in surgery associated with this complaint.The screws were unable to be returned to the manufacturer as they remain in the patient.No additional information available.

• Brand Name: CERVALIGN
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• 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: 23304645
• Report Number: 3005031160-2025-00037
• Device Sequence Number: 15959464
• Product Code: KWQ
• UDI-Device Identifier: 00810076561530
• UDI-Public: 00810076561530
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: 66-VST-40-16
• Device Lot Number: 351105
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male