Vital MIS Spinal Fixation System 07.02063.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663125536), received between Nov 13, 2025 and Mar 24, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INTRA-OPERATIVELY, A VITALITY T20 FINAL DRIVER TIP DID NOT FIT INTO CROSSLINK SCREWS. AN ADDITIONAL T20 DRIVER WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT THE TIP OF THE DRIVER WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677198 ↗
• MalfunctionNov 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE A CONNECTOR WAS BEING LOOSENED INTRA-OPERATIVELY, IT BECAME CROSS-THREADED/JAMMED, CAUSING A VITAL FINAL DRIVER TIP TO FRACTURE AND THE TIP OF ANOTHER TO DEFORM. THE PROCEDURE WAS COMPLETED USING REPLACEMENT PRODUCTS. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A FIVE MINUTE DELAY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618800 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE A CONNECTOR WAS BEING LOOSENED INTRA-OPERATIVELY, IT BECAME CROSS-THREADED/JAMMED, CAUSING A VITAL FINAL DRIVER TIP TO FRACTURE AND THE TIP OF ANOTHER TO DEFORM. THE PROCEDURE WAS COMPLETED USING REPLACEMENT PRODUCTS. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A FIVE MINUTE DELAY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618769 ↗
• MalfunctionNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT VITALITY T20 DRIVER WITH A FRACTURED TIP, AND A VITALITY T20 DRIVER WITH A DEFORMED TIP WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23547856 ↗
• MalfunctionNov 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT VITALITY T20 DRIVER WITH A FRACTURED TIP, AND A VITALITY T20 DRIVER WITH A DEFORMED TIP WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23547848 ↗