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

Model Number	66-DRIVER-SG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of product complaints on 11/20/2025.Replacements were requested for four system screwdrivers that would not function as intended.It was reported that some of the system screwdrivers would not effectively engage and retain system screws, and a couple with broken distal tips.It is unclear how many instruments were not engaging screws, and how many had broken distal tips.An rma number was issued for return of the complaint screwdrivers, which as of 12/17/2025 were not received at the manufacturer for assessment.Repeated attempts to gather relevant complaint incident details to determine the impact to patient and/or procedure were unsuccessful.
Additional Manufacturer Narrative
Visual and functional assessments were not performed due to the complaint instruments not being returned to the manufacturer.Dhr reviews could not be performed due to the lot numbers of the complaint instruments not being identified.There have been four other complaints of similar nature for the system drivers with broken distal tips in the past 12 months.The manufacturer will continue to monitor for reports of broken system screwdrivers and perform complaint investigations and submissions of fda 3500a reports as appropriate.A supplemental report will be submitted if/when additional information is received that can determine the number of instrument malfunctions and the impact to patient and/or procedure.

• 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: 23832035
• Report Number: 3005031160-2025-00043
• Device Sequence Number: 14722636
• Product Code: KWQ
• UDI-Device Identifier: 00810076561899
• UDI-Public: 00810076561899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211408
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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-DRIVER-SG
• 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: 11/20/2025
• Initial Report FDA Received Date: 12/17/2025
• 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
• Patient Sex: Unknown