XIA 3 48236053Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540560889), received between Aug 9, 2016 and Dec 10, 2021 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2021Fracture; Fracture

  THE PATIENT WAS IMPLANTED WITH A XIA CONSTRUCT ON (B)(6) 2017. ON (B)(6) 2018, IT WAS REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED AND THE RIGHT SIDE XIA II ROD FRACTURED AFTER THE PATIENT EXPERIENCED A FALL. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD BEEN REVISED ON (B)(6) 2021 TO ADDRESS THE PREVIOUSLY REPORTED DISENGAGED SCREW AND FRACTURED ROD, AS WELL AS A SECOND ROD FRACTURE (ON THE LEFT SIDE). DURING REVISION SURGERY, A XIA 3 POLYAXIAL SCREW WAS NOTED TO BE LOOSE AND TWO XIA 3 MULTIAXIAL CROSSLINKS WERE REMOVED. EVALUATION OF THE RETURNED DEVICES IDENTIFIED THAT BOTH CROSSLINKS WERE FRACTURED. THIS RECORD CAPTURES THE FIRST OF TWO XIA 3 MULTIAXIAL CROSSLINKS REMOVED DURING THE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977803 ↗
• MalfunctionJun 27, 2018Break; Fracture; Fracture

  A PLIF SURGERY ON (B)(6) 2010 RESULTED IN AN ADJACENT VERTEBRAL DISORDER. AS A RESULT, REVISION SURGERY WAS CONDUCTED ON (B)(6) 2018 DURING WHICH THE NUT ON THE CROSSLINK BROKE WHILE TIGHTENING IT WITH THE NUT DRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE CROSSLINK. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED DURING REVISION SURGERY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7644313 ↗
• MalfunctionAug 9, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED; DURING SURGERY, WHEN THE SURGEON PLACED THE CONNECTOR AND TIGHTENED THE CENTRAL NUT THE NUT BROKE. THE SURGEON USED A SPARE ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5858358 ↗