Vital™ Navigation System 854M0021Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887868310232), received between Mar 8, 2022 and Jan 12, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO EXTEND A CONSTRUCT, THE TIP OF A VITALITY NAVIGATION DRIVER STRIPPED. THE SURGERY WAS COMPLETED USING THE NAVIGATION DRIVER, AND THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038652 ↗
• MalfunctionJun 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO NAVIGATED VITAL DRIVERS BROKE DURING SURGERY WHEN PLACING A SCREW; THE STAR TIP BROKE ON BOTH AND BOTH WERE RETRIEVED. THE SCREW WAS ALL THE WAY IN AND FINAL TIGHTENED WHEN THE EVENT HAPPENED; THERE WAS NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329946 ↗
• MalfunctionJun 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO NAVIGATED VITAL DRIVERS BROKE DURING SURGERY WHEN PLACING A SCREW; THE STAR TIP BROKE ON BOTH AND BOTH WERE RETRIEVED. THE SCREW WAS ALL THE WAY IN AND FINAL TIGHTENED WHEN THE EVENT HAPPENED; THERE WAS NO PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329834 ↗
• MalfunctionJan 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THREE VITALITY DRIVERS FRACTURED WHEN TRYING TO REMOVE A STUCK ILIAC SCREW. THE SCREW WAS ULTIMATELY ABLE TO BE REMOVED AND REPLACED WITH A SHORTER SCREW. THIS RESULTED IN A 20 MINUTE DELAY TO THE PROCEDURE BUT NO OTHER PATIENT IMPACT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584934 ↗
• MalfunctionFeb 13, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO VITALITY CONNECTORS BROKE, THE TIP OF ONE VITALITY T20 FINAL DRIVER BROKE, THE TIP OF A VITALITY T27 DRIVER TWISTED, AND THE TIPS OF TWO VITAL NAVIGATION T27 DRIVERS TWISTED INTRA-OPERATIVELY. OTHER CONNECTORS AND DRIVERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO THE PROCEDURE THAT DID NOT LEAD TO PATIENT IMPACTS. THIS IS REPORT SIX OF SIX FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362892 ↗
• MalfunctionFeb 13, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO VITALITY CONNECTORS BROKE, THE TIP OF ONE VITALITY T20 FINAL DRIVER BROKE, THE TIP OF A VITALITY T27 DRIVER TWISTED, AND THE TIPS OF TWO VITAL NAVIGATION T27 DRIVERS TWISTED INTRA-OPERATIVELY. OTHER CONNECTORS AND DRIVERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO THE PROCEDURE THAT DID NOT LEAD TO PATIENT IMPACTS. THIS IS REPORT FIVE OF SIX FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362884 ↗
• MalfunctionMar 8, 2022Material Deformation; Material Deformation

  THE TIP OF A SCREW INSERTER WAS FOUND TO BE TWISTED DURING A ROUTINE INSPECTION. THE SPECIFIC SURGICAL OR PATIENT INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13690653 ↗