XIA 3 482315530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540562029), received between Oct 9, 2017 and Oct 9, 2017 — classified as 2 malfunctions.

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.

• MalfunctionOct 9, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE METAL WAS BEING REMOVED, 3 SCREWS SHOWED WERE BROKEN. NOT ENOUGH CEMENT WAS PRESSED INTO CARTRIDGE. NO FURTHER IMPLANTS WERE IMPLANTED INTO PATIENT BECAUSE HEALING IS NEEDED FIRST. THE 3 BROKEN DEVICES STAY IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6932433 ↗
• MalfunctionOct 9, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE METAL WAS BEING REMOVED, 3 SCREWS SHOWED WERE BROKEN. NOT ENOUGH CEMENT WAS PRESSED INTO CARTRIDGE. NO FURTHER IMPLANTS WERE IMPLANTED INTO PATIENT BECAUSE HEALING IS NEEDED FIRST. THE 3 BROKEN DEVICES STAY IN THE PATIENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6930368 ↗