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

Model Number	66-354
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 1/27/2026.It was reported that during a routine post operative follow up appointment, locking cams of an anterior cervical plate were identified as having malfunctioned, which allowed for an implant screw to migrate from its intended position.A lateral x-ray image was provided, which showed the caudad implant screw was backed out beyond the surface of the plate implant.The patient and surgeon were unaware of the screw migration until the six month follow up appointment.The implant was removed on (b)(6) 2026 without any known complications or impact to the patient, whose health status was reported to be good.The implant was not available to be returned for assessment.
Additional Manufacturer Narrative
Additional imaging was provided of the explanted plate and associated screws.The images provided showed that 3 of the 8 locking cams of the cervical plate implant were fractured.Anodization of the plate implant was extensively worn, and there was a titanium material curl on the back side of the plate.The screws used to place the cervical plate also had worn anodization present.It cannot be determined if the condition is due to the implantation or explantation process.A dhr review was performed for cervical plate lot# 408154 and there were no manufacturing anomalies identified.The implant lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/11/2021.An implant screw to migrate if the locking cam of the implant plate did not effectively retain the screw.It may be possible for locking cams of an implant plate to not effectively retain implant screws if they were not fully seated or if the locking cams were damaged.If implant screws are not fully seated it may be possible for the locking cams to become damaged and not effectively retain the screws as intended.It may also be possible that as anatomy settled post-operatively, the screws placed pressure on the locking cams allowing a screw to migrate as observed.The root cause of this complaint cannot be reliably determined.The system ifu provides postoperative patient guidance, as well as possible adverse effects.The system ifu states, "the implant is not intended to be permanent.The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant.Metallic implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in you, active patients." there have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of migrated implants and perform complaint investigations and regulatory reporting as appropriate.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• 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: 24446967
• Report Number: 3005031160-2026-00006
• Device Sequence Number: 10300631
• Product Code: KWQ
• UDI-Device Identifier: 00810076561271
• UDI-Public: 00810076561271
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K211408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 02/25/2026

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: 66-354
• Device Lot Number: 408154
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 100 KG