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	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by surface scratches and worn laser marking.The distal tip of the instrument was fractured and not present as reported.A functionality assessment was not performed due to the damaged condition of the returned driver, which was removed from distributable inventory.A dhr review was performed for lot# 386613 and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 3/22/2021.It may be possible for the distal tip of the system screwdriver to be broken if excessive rotational force was applied, or if the screwdriver was shifted out of alignment while engaged with a system implant screw.It may be possible for the distal tip of the screwdriver to be broken if excessive rotational force was applied, or if the screwdriver was shifted out of alignment while engaged with a system implant screw.The root cause of the broken distal tip could not be reliably determined.The complaint investigation suggests the possibility that the screwdriver had excessive rotational force applied or was shifted out of alignment while engaged with a system implant screw.There have been three other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of malfunctioned system instruments and perform complaint investigations as appropriate.
Event or Problem Description
The manufacturer was made aware of a product complaint on 2/20/2025.It was reported that the distal tip of a system screwdriver was broken when tightening an implant screw.The fractured tip was recovered, and an alternate available instrument was utilized to successfully complete the procedure.There was no known patient complications associated with this complaint.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 2/24/2025.

• 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: 21553925
• Report Number: 3005031160-2025-00006
• Device Sequence Number: 8119936
• Product Code: KWQ
• UDI-Device Identifier: 00846468088088
• UDI-Public: 00846468088088
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/07/2025

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: 386613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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: 54 YR
• Patient Sex: Female