Vitality® 07.02027.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024007383), received between Jul 13, 2021 and Feb 13, 2023 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Fracture; Fracture

  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 ONE OF SIX FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362866 ↗
• MalfunctionJul 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTIES WITH SET SCREW TIGHTENING INTRA-OPERATIVELY. THE SET SCREWS ON THREE CROSS CONNECTORS CROSS-THREADED, THE DRIVER TIP FRACTURED, AND THE TORQUE HANDLE DID NOT LIMIT THE TORQUE. THE DRIVER TIP WAS RECOVERED, THE CROSS-CONNECTORS WERE REMOVED, AND ALTERNATIVE CROSS-CONNECTORS WERE USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158197 ↗
• MalfunctionJul 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTIES WITH SET SCREW TIGHTENING INTRA-OPERATIVELY. THE SET SCREWS ON THREE CROSS CONNECTORS CROSS-THREADED, THE DRIVER TIP FRACTURED, AND THE TORQUE HANDLE DID NOT LIMIT THE TORQUE. THE DRIVER TIP WAS RECOVERED, THE CROSS-CONNECTORS WERE REMOVED, AND ALTERNATIVE CROSS-CONNECTORS WERE USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158194 ↗
• MalfunctionJul 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTIES WITH SET SCREW TIGHTENING INTRA-OPERATIVELY. THE SET SCREWS ON THREE CROSS CONNECTORS CROSS-THREADED, THE DRIVER TIP FRACTURED, AND THE TORQUE HANDLE DID NOT LIMIT THE TORQUE. THE DRIVER TIP WAS RECOVERED, THE CROSS-CONNECTORS WERE REMOVED, AND ALTERNATIVE CROSS-CONNECTORS WERE USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158188 ↗