XIA 3 482315535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540562036), received between Jun 28, 2018 and Jun 28, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL SURGERY ON (B)(6) 2015. AFTER MAKING THE RECOVERY AS ESTABLISHED BY THE DOCTOR, PATIENT CONTINUED IN PAIN. ON (B)(6) 2016 THE SURGEON REQUESTED A COMPUTED TOMOGRAPHY WHERE IT WAS EVIDENT THAT THE PLACED IMPLANT IS BROKEN. THIS RESULTED IN A REVISION SURGERY WHICH WAS PERFORMED ON (B)(6) 2016.

  Patient problems: Injury; Pain

  MAUDE report 7649100 ↗
• InjuryJun 28, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL SURGERY ON (B)(6) 2015. AFTER MAKING THE RECOVERY AS ESTABLISHED BY THE DOCTOR, PATIENT CONTINUED IN PAIN. ON (B)(6) 2016 THE SURGEON REQUESTED A COMPUTED TOMOGRAPHY WHERE IT WAS EVIDENT THAT THE PLACED IMPLANT IS BROKEN. THIS RESULTED IN A REVISION SURGERY WHICH WAS PERFORMED ON (B)(6) 2016.

  Patient problems: Injury; Pain

  MAUDE report 7649050 ↗