XIA 4 5 48132601Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540539663), received between Mar 10, 2016 and Nov 24, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA TITANIUM 4.5 VITALIUM RODS FRACTURED APPROXIMATELY TWO YEARS POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED. THIS RECORD CAPTURES THE FIRST OF THE TWO FRACTURED XIA 4.5 RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868377 ↗
• InjuryNov 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA TITANIUM 4.5 VITALIUM RODS FRACTURED APPROXIMATELY TWO YEARS POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED. THIS RECORD CAPTURES THE SECOND OF THE TWO FRACTURED XIA 4.5 RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868371 ↗
• InjuryMar 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT A XIA TITANIUM 4.5 VITALLIUM ROD FRACTURED POST-OPERATIVELY. SURGERY WAS PERFORMED BY GROWING ROD METHOD, WITH THE FIRST EXTENSION SCHEDULED FOR (B)(6) 2020. AN EXAMINATION OF THE PATIENT REVEALED A BROKEN ROD BEFORE FIRST EXTENSION COULD BE PERFORMED. REVISION WAS PERFORMED TO REPLACE THE ROD.

  Patient problems: Injury

  MAUDE report 9836752 ↗
• InjuryDec 26, 2019Fracture; Fracture

  PHYSICIAN REPORTED THAT INTERBODY FUSION WAS DONE FROM T3 TO L2 FOR SPINAL SCOLIOSIS. THE LEFT XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM FRACTURED POST- OPERATIVELY. REVISION SURGERY OCCURRED AND BOTH THE LEFT AND RIGHT RODS WERE REPLACED. THIS RECORD CAPTURES THE LEFT SIDE ROD FRACTURE.

  Patient problems: Injury

  MAUDE report 9521041 ↗
• InjuryDec 6, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROD BROKE IN HALF AND SCREWS CAME OUT POST-OPERATIVELY. PATIENT REPORTEDLY HAD FALL IN (B)(6) OF 2017 IN WHICH SHE TRIPPED OVER A CHAIR AND FELL ON THEIR KNEES. THE PATIENT WAS IN PAIN, COULDN'T WALK, TROUBLE BREATHING AND COULDN'T LIFT ARM. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REPLACE HARDWARE.

  Patient problems: Ambulation or Postural Difficulties; Dyspnea; Fall; Injury; Pain

  MAUDE report 8139735 ↗
• InjuryMar 8, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE ROD BROKE.

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

  MAUDE report 7323863 ↗
• InjuryMar 6, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE ROD BROKE POST SURGERY. REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7318825 ↗
• InjuryMar 10, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; RODS WERE FOUND TO BE BROKEN AND WERE REVISED.

  Patient problems: Injury; No Code Available

  MAUDE report 5492130 ↗