Vital Navigation System 854M0021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663248679), received between Nov 13, 2025 and Nov 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A VITALITY T27 DRIVER TIP TWISTED DURING A CONSTRUCT EXTENSION SURGERY. THE DRIVER WAS NOT ABLE TO BE USED BUT A REPLACEMENT ITEM WAS OPENED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610277 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN PUTTING IN ILIAC SCREWS, THE TIP OF A VITAL NAVIGATION DRIVER TWISTED. THE SURGERY WAS COMPLETED WITH A BACKUP, AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609992 ↗
• MalfunctionNov 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A VITAL NAVIGATION DRIVER WITH A DEFORMED TIP WAS DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23547289 ↗