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

Model Number	66-114
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2025.It was reported that a surgeon noticed metal shavings after implanting a system plate and screws.There were no patient complications or delay in surgery associated with this complaint.The implants were unable to be returned to the manufacturer as they remain in the patient.No additional information available.Report 1 of 2.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the complainant.No device was returned for evaluation; further no photographs were provided.Operative notes and/or medical records were not provided for review of usage/technique.It is unknown if the metal shavings came from the plate, screws, or another unknown source.A review of manufacturing records was unable to be completed as the lot information of the product was not available.No further investigation was able to be performed at this time.A root cause was unable to be determined with the information provided, however it may be possible that if the screws weren't placed directly in the center of the holes in the plates, they may have unintentional contact and could result in shavings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.There have been zero other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of system implants and perform complaint investigations as appropriate.

• Brand Name: CERVALIGN
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 22342204
• Report Number: 3005031160-2025-00021
• Device Sequence Number: 4825707
• Product Code: KWQ
• UDI-Device Identifier: 00810076561073
• UDI-Public: 00810076561073
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 66-114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Male