XIA 3 482316550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540562258), received between Aug 3, 2016 and Jun 25, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Fracture; Fracture

  A PATIENT WAS REVISED TO ADDRESS A FRACTURED XIA POLYAXIAL SCREW AT RIGHT S1. THE PATIENT REPORTED PAIN AND CT SCAN IDENTIFIED THE FRACTURED SCREW. THE FRACTURED SHAFT WAS UNABLE TO BE REMOVED DURING REVISION AND REMAINS IN THE PATIENT; THE REPLACEMENT SCREW WAS PLACED IN THE BONE SLIGHTLY LATERAL TO THE FRACTURED SHAFT.

  Patient problems: Pain

  MAUDE report 19611070 ↗
• InjuryAug 3, 2016Break; Noise, Audible

  IT WAS REPORTED THAT A SCREW HAD BROKEN 3-4 MONTHS AFTER PRIMARY SURGERY AND REVISION SURGERY WAS NEEDED TO CORRECT IT. THE SCREW WAS IN S1. THE CUSTOMER REPORTED THAT THE PATIENT PRESENTED WITH A SQUEAK NOISE.

  Patient problems: No Code Available

  MAUDE report 5842983 ↗