XIA II 03822601Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540539656), received between Jul 1, 2016 and Dec 10, 2021 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 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 SECOND FRACTURED XIA II VITALIUM ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977777 ↗
• InjuryOct 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA II VITALIUM RODS FRACTURED AT L5/6 POST-OPERATIVELY. THE PATIENT WAS REVISED TO REPLACE THE FRACTURED RODS AND RE-FIX THE CONSTRUCT. THIS RECORD CAPTURES THE SECOND OF THE TWO XIA II VITALIUM RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704490 ↗
• InjuryOct 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA II VITALIUM RODS FRACTURED AT L5/6 POST-OPERATIVELY. THE PATIENT WAS REVISED TO REPLACE THE FRACTURED RODS AND RE-FIX THE CONSTRUCT. THIS RECORD CAPTURES THE FIRST OF THE TWO XIA II VITALIUM RODS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704484 ↗
• InjuryJun 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA II VITALIUM RODS 'BROKE' POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE RODS WERE REPLACED. THIS RECORDS REPRESENTS THE SECOND OF THE TWO RODS.

  Patient problems: Pain

  MAUDE report 10176433 ↗
• InjuryJun 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO XIA II VITALIUM RODS 'BROKE' POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE RODS WERE REPLACED. THIS RECORDS REPRESENTS THE FIRST OF THE TWO RODS.

  Patient problems: Pain

  MAUDE report 10175729 ↗
• InjuryOct 22, 2019Break; Fracture; Fracture

  A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED BACK PAIN POST-OPERATIVELY. IMAGING SHOWED TWO BROKEN XIA II VITALIUM RODS. REVISION SURGERY WAS PERFORMED. THIS RECORD CAPTURES THE FIRST OF THE TWO RODS.

  Patient problems: Injury; Pain

  MAUDE report 9220805 ↗
• InjuryOct 22, 2019Break; Fracture; Fracture

  A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED BACK PAIN POST-OPERATIVELY. IMAGING SHOWED TWO BROKEN XIA II VITALIUM RODS. REVISION SURGERY WAS PERFORMED. THIS RECORD CAPTURES THE SECOND OF THE TWO RODS.

  Patient problems: Injury; Pain

  MAUDE report 9220717 ↗
• MalfunctionFeb 6, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN ROD WAS NOTICED ON A PATIENT'S X-RAY UPON A FOLLOW UP VISIT. THE HARDWARE WAS REVISED DURING REVISION SURGERY. PARTS OF THE ROD WERE REMOVED AND NEW RODS WERE CONNECTED TO LOWER PARTS OF THE OLD ROD. IT WAS THEN SECURED INTO PLACE WITH EXISTING SCREWS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7244820 ↗
• InjuryMar 15, 2017Break; Fracture; Loose or Intermittent Connection; Fracture

  IT WAS REPORTED THAT: COBALT CHROME ROD BROKEN. BLOCKERS LOOSE AT T10, T11, L4, L5, S1, ILIAC BOLT AND OFFSET CONNECTOR. SCREW LOOSE AT LEFT S1. MULTIPLE LEVELS OF NONUNION. REPLACED ROD AND AFFECTED SCREWS.

  Patient problems: Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6408141 ↗
• InjuryOct 31, 2016Disassembly; Disassembly; Device Slipped

  IT WAS REPORTED THAT; RODS SLIPPED THROUGH THE TULIP HEADS OF THE PEDICEL SCREWS

  Patient problems: Injury; No Code Available

  MAUDE report 6067939 ↗
• MalfunctionOct 31, 2016Disassembly; Disassembly; Device Slipped

  IT WAS REPORTED THAT; RODS SLIPPED THROUGH THE TULIP HEADS OF THE PEDICEL SCREWS.

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

  MAUDE report 6067913 ↗
• InjuryJul 1, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT; X PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012. TH5-S2AI WERE FIXED. AFTER THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 DUE TO A ROD BREAKAGE. IN THE REVISION, THE BONE GRAFT HAS BEEN SUBJECTED AND FIVE RODS WERE USED FOR FIXATION. THIS EVENT IS RELATED TO (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 5766312 ↗
• InjuryJul 1, 2016Break; Fracture; Difficult to Remove; Material Deformation; Fracture

  IT WAS REPORTED THAT; THE SECOND REVISION SURGERY WAS PERFORMED DUE TO THE ROD BREAKAGE. THE LEFT AND RIGHT OF THE ROD WERE BROKE IN TWO LEVELS (LEFT: L4/5 AND L3/4, RIGHT: L5/S1 AND L4/5). DURING THE REVISION SURGERY, THE SURGEON TRIED TO REMOVE THE CLOSED POLYAXIAL SCREW ON LEFT S2AI. BUT THE SCREW WAS NOT ABLE TO REMOVED AND THE TIP OF THE DRIVERS WAS DEFORMED. THE SCREW SHAFT WAS REMAINED. THIS EVENT IS RELATED TO (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 5766291 ↗