XIA 3 482318540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540598585), received between Jun 30, 2016 and Jun 28, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionJun 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE TULIP OF A XIA 3 TITANIUM POLYAXIAL SCREW DISENGAGED DURING IMPLANTATION. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT'S BONE AND THE PROCEDURE WAS COMPLETED FOLLOWING A FIVE-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847976 ↗
• InjuryMar 10, 2021Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT THE TULIP OF A XIA 3 TITANIUM POLYAXIAL SCREW AT S1 DISENGAGED 2 MONTHS POST-OPERATIVELY. UPON REVISION, THE SURGEON FOUND THE TULIP OF THE SCREW TO HAVE BROKEN OFF FROM THE SCREW THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455195 ↗
• MalfunctionJun 30, 2016Device Slipped

  IT WAS REPORTED THAT; TULIP POPPED OFF SCREW WHEN IT WAS FINAL TIGHTENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5762244 ↗