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

Model Number	66-DRIVER-SG
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned driver showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal tip of the driver was fractured as reported, and the retention collar was misshaped preventing appropriate system screw engagement and retention.A functionality assessment was not performed due to the damaged condition of the complaint instrument, which was removed from distributable inventory.A dhr review was performed for complaint instrument lot# and there were no manufacturing deficiencies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/22/2019.The root cause of this complaint cannot be reliably determined.It may be possible for the distal tip of the driver to be broken if excessive rotational force was applied, or if the driver was shifted out of alignment while engaged with a system screw.There have been four other complaints of similar nature for this system driver in the past 12 months.The manufacturer will continue to monitor for reports of broken system drivers and perform complaint investigations as appropriate.
Event or Problem Description
The manufacturer was made aware of a product complaint on 6/23/2025.It was reported that while final tightening a system screw, the distal tip of a system screwdriver was broken and requested to be replaced.There were no known patient complications or delay in treatment associated with this complaint, an alternate available instrument was used to successfully complete the procedure.A return authorization number was issued for the return of the complaint instrument, which was received at the manufacturer for assessment on 7/03/2025.

• 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: 22511843
• Report Number: 3005031160-2025-00024
• Device Sequence Number: 8745637
• Product Code: HXX
• UDI-Device Identifier: 00810076561899
• UDI-Public: 00810076561899
• 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
• 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): 07/15/2025

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-DRIVER-SG
• Device Lot Number: 354398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• 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: 57 YR
• Patient Sex: Unknown