XIA 3 482316545Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540562241), received between Jun 8, 2016 and Jul 3, 2024 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A NON-UNION ISSUE AND DISCOVERED A FRACTURED XIA 3 TITANIUM POLYAXIAL SCREW TULIP AT L3, APPROXIMATELY EIGHT YEARS AFTER IMPLANTATION. THE PATIENT HAD REPORTED EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 19667182 ↗
• InjuryNov 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT A XIA 3 POLYAXIAL SCREW FRACTURED POST-OPERATIVELY, DUE TO CONSTRUCT INSTABILITY. REVISION SURGERY HAS BEEN PERFORMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790905 ↗
• InjuryFeb 2, 2021Migration; Migration

  IT WAS REPORTED THAT 4 XIA 3 TITANIUM POLYAXIAL SCREWS WERE LOOSE AND MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED AND THE SCREWS EXPLANTED. THIS REPORT REPRESENTS THE FIRST OF THE 4 XIA 3 TITANIUM POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269766 ↗
• InjuryFeb 2, 2021Migration; Migration

  IT WAS REPORTED THAT 4 XIA 3 TITANIUM POLYAXIAL SCREWS WERE LOOSE AND MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS BEEN PERFORMED AND THE SCREWS EXPLANTED. THIS REPORT REPRESENTS THE SECOND OF THE 4 XIA 3 TITANIUM POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269667 ↗
• MalfunctionSep 19, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN FUSED FROM L3-S1. AS THEY WERE TAKING THE INSTRUMENTATION OUT OF PATIENT, SCREW WAS ALREADY BROKEN. NO HARM WAS DONE TO THE PATIENT AND LEFT THE BOTTOM HALF OF THE SCREW IN THE PATIENT.

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

  MAUDE report 6876218 ↗
• InjuryMay 19, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2017, IT WAS REMOVED THE BROKEN THE SCREW, BUT THE TIP OF BROKEN SCREW WAS REMAINED IN PATIENT. AT THE TIME OF INITIAL SURGICAL PROCEDURE, IT WAS ASSUMED A POSSIBILITY OF BREAKAGE SCREW.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 6579430 ↗
• MalfunctionOct 27, 2016Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT; IT WAS ALSO DISCOVERED THAT THE PATIENT HAD MIGRATION OF THE PEEK CAGE, AND LOOSENING OF SCREWS.

  Patient problems: Injury

  MAUDE report 6060620 ↗
• MalfunctionAug 29, 2016Positioning Problem

  IT IS REPORTED THAT DURING A SURGERY PROCEDURE THE SURGEON OBSERVED THAT THE ROD COULDN'T BE FIXED INTO THE SCREW, AS SPECIFIED. ALTHOUGH FULL TIGHTENING OF THE SCREW A PART OF PLOYAXIALITY STILL REMAINS. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5912091 ↗
• MalfunctionJul 26, 2016Break

  IT WAS REPORTED THAT; ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY. ON (B)(6) 2016, THE SURGEON FOUND THROUGH THE MRI IMAGE THAT THE SCREW WAS BROKEN (L4). THEREFORE THE SURGEON IS MONITORING FOR THE PATIENT NOW. THE REVISION SURGERY IS NOT PLANNING NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821738 ↗
• InjuryJun 8, 2016Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; BROKEN SCREWS DISCOVERED UPON REVISION SURGERY. TWO SCREWS WERE DISCOVERED TO BE FRACTURED THROUGH THE MID-SHAFT OF THE SCREW. ISSUE WAS NOTICED DURING IMAGING AND CONFIRMED WHEN THE SCREWS WERE REMOVED. SCREWS WERE REPLACED IN THE REVISION SURGERY. THE BROKEN SCREWS WERE NOT THE PRIMARY REASON FOR THE REVISION. THE PRIMARY REASON FOR THE REVISION SURGERY WAS ADJACENT LEVEL DISEASE AT L2-3. UPDATE 16-MAY-2016: CT IMAGES OF BROKEN SCREWS AVAILABLE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5707555 ↗