XIA 3 482319580Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540598745), received between Sep 21, 2018 and Feb 16, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIPS OF TWO XIA 3 POLYAXIAL SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24356898 ↗
• MalfunctionFeb 16, 2026Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIPS OF TWO XIA 3 POLYAXIAL SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24356412 ↗
• InjuryMay 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT 2 MONTHS AFTER IMPLANTATION, A RIGHT-SIDE XIA 3 BLOCKER AND A LEFT-SIDE XIA 3 BLOCKER MIGRATED, AND A LEFT-SIDE XIA 3 POLYAXIAL SCREW FRACTURED. THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER TO ADDRESS THE MIGRATED BLOCKERS AND FRACTURED SCREW. THE PATIENT EXPERIENCED MILDLY INCREASING LOW BACK AND PELVIC PAIN. THIS REPORT IS FOR THE XIA 3 POLYAXIAL SCREW.

  Patient problems: Pain

  MAUDE report 16908172 ↗
• MalfunctionSep 21, 2018Device Slipped; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER PLACING THE NAIL WITH BLOCKER, THE SCREW HEAD PULL OUT WAS NOTICED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898487 ↗