XIA 3 482317540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540562340), received between Mar 31, 2016 and May 31, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW BROKE OFF FROM THE SCREW SHAFT POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547556 ↗
• InjuryAug 27, 2020Fracture; Fracture

  A PHYSICIAN REPORTED A PATIENT HAS BEEN EXPERIENCING BACK PAIN AND IMAGING INDICATES TWO FRACTURED XIA 3 POLYAXIAL SCREWS AT S1. REVISION SURGERY HAS BEEN PERFORMED. THIS RECORD WILL CAPTURE THE SECOND OF TWO SCREWS.

  Patient problems: Pain

  MAUDE report 10463278 ↗
• InjuryAug 27, 2020Fracture; Fracture

  A PHYSICIAN REPORTED A PATIENT HAS BEEN EXPERIENCING BACK PAIN AND IMAGING INDICATES TWO FRACTURED XIA 3 POLYAXIAL SCREWS AT S1. REVISION SURGERY HAS OCCURRED. THIS RECORD WILL CAPTURE THE FIRST OF TWO SCREWS.

  Patient problems: Pain

  MAUDE report 10463277 ↗
• MalfunctionFeb 24, 2017Disconnection; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; TULIP HEAD DISENGAGED FROM THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6358170 ↗
• InjuryNov 23, 2016Mechanical Problem; Unintended Movement; Mechanical Problem; Connection Problem; Unintended Movement

  IT WAS REPORTED THAT; THE PROCEDURE WAS PLIF. ATTEMPT TO TIGHTEN THE L5 LEFT SCREW BY TORQUE WRENCH DURING FINAL FASTING. IT COULDN'T CONNECT THE ANTI-TORQUE-KEY ON SCREW HEAD DUE TO PRESSED BY OUTER MUSCLE. ATTEMPTED TO START A FINAL FASTEN AGAIN FOR L4 LEFT SCREW AFTER CONNECTED THE ANTI-TORQUE-KEY WITH L4 LEFT SCREW HEAD. BUT THERE WAS CUT OUT THE L5 LEFT SCREW UNDER ABOUT 12N. REMOVED THE BLOCKER AND THE ROD BOTH. INSERTED THE L5 LEFT SCREW TO PROGRESS IN A NEW DIRECTION, HOWEVER THERE WAS FOUND A MOVEMENT OF SCREW AGAIN. THEN CREATED ANOTHER NEW SCREW HOLE AND IMPLANTED OTHER SCREW WITH NO COMPRESSION BUT IT REMAINED A SLIGHT MOTION ON SCREW. COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCE REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6125368 ↗
• MalfunctionMar 31, 2016Material Separation

  IT WAS REPORTED THAT; THE TULIP HEAD SEPARATED FROM THE SCREW WHILE REDUCING A SPONDY WITH THE CORKSCREW PERSUADER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5537687 ↗