XIA 3 482317050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540562487), received between Jan 3, 2017 and Feb 2, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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.

• InjuryFeb 2, 2021Migration; Migration

  IT WAS REPORTED THAT 4 XIA 3 TITANIUM POLYAXIAL SCREWS WERE LOOSE AND MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED AND THE SCREWS EXPLANTED. THIS REPORT REPRESENTS THE THIRD OF THE 4 XIA 3 TITANIUM POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269835 ↗
• InjuryFeb 2, 2021Migration; Migration

  IT WAS REPORTED THAT 4 XIA 3 TITANIUM POLYAXIAL SCREWS WERE LOOSE AND MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED AND THE SCREWS EXPLANTED. THIS REPORT REPRESENTS THE FOURTH OF THE 4 XIA 3 TITANIUM POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269751 ↗
• InjuryJan 3, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; SCREWS WERE IMPLANTED (B)(6) 2015, SURGEON BECAME AWARE OF BROKEN SCREW AT END OF THE CONSTRUCT ON SCOLIOSIS FUSION CASE.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 6219891 ↗