XIA 3 48232480Recalls & reported problems
Stryker Corporation · CP TI ROD · Class 2 · Implant
Quick summary
This Stryker XIA 3 rod is a titanium spinal implant used with pedicle screw systems to hold the spine steady. Most of the 31 reports describe the rod breaking or fracturing, sometimes years after it was implanted, often after a fall or with no obvious trigger, and several times more than one rod in the same patient. Patients are commonly treated for pain and sometimes need follow-up surgery. No deaths were reported and there were 20 injuries.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04546540560575), received between Feb 9, 2016 and Jul 29, 2026 — classified as 22 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (32 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.
Reports received per month
Most reported problems
Device problems
- Fracture32
- Break4
- Adverse Event Without Identified Device or Use Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Pain10
- Back pain3
- Injury3
- Insufficient Information3
- Inflammation2
- Muscle Weakness/Atrophy2
- No Code Available2
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Fracture
It was reported that a patient sustained a fall at home approximately 15 months post-operatively and experienced thoracic back pain. Imaging revealed that two Xia 3 Rods had fractured. The patient is scheduled to receive specialized medical care, however hospitalization nor surgical treatment have been required. This report captures the second of two Rods.
Patient problems: Back pain
MAUDE report 50074691 ↗InjuryJul 29, 2026Fracture
It was reported that a patient sustained a fall at home approximately 15 months post-operatively and experienced thoracic back pain. Imaging revealed that two Xia 3 Rods had fractured. The patient is scheduled to receive specialized medical care, however hospitalization nor surgical treatment have been required. This report captures the first of two Rods.
Patient problems: Back pain
MAUDE report 50074679 ↗InjuryJul 21, 2026Fracture
A HEALTH PROFESSIONAL REPORTED THAT A XIA 3 ROD WAS OBSERVED TO HAVE FRACTURED APPROXIMATELY 3 YEARS AND 8 MONTHS POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE EVENT RESULTED IN HOSPITALIZATION OR ITS EXTENSION. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED AND THE PATIENT REPORTED NOT EXPERIENCING ANY PAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25898679 ↗InjuryApr 14, 2026Fracture
ADDITIONAL IMAGING PROVIDED FROM THE FIELD INDICATED THAT THREE RODS FRACTURED. THIS REPORT CAPTURES THE FIRST OF THREE RODS.
Patient problems: Back pain
MAUDE report 24877573 ↗InjuryDec 23, 2025Fracture; Fracture
A HEALTH PROFESSIONAL REPORTED THAT AN UNKNOWN ROD FRACTURED INTRA-OPERATIVELY AND THAT THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE CONSEQUENCES.
Patient problems: Insufficient Information
MAUDE report 23882515 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO XIA 3 TITANIUM RODS FRACTURED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED "ISSUE RELATED TO BONE DESTRUCTION". NO REVISION SURGERY HAS BEEN REPORTED. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 22069983 ↗MalfunctionMay 21, 2025Fracture; Fracture
InjuryDec 27, 2024Fracture; Fracture
(B)(6) REPORTED THAT A PATIENT WITH PAIN IS TO BE REVISED APPROXIMATELY 3 YEARS POST-OPERATIVELY TO ADDRESS THREE FRACTURED RODS. THIS REPORT CAPTURES THE XIA 3 ROD.
Patient problems: Pain
MAUDE report 21025598 ↗MalfunctionOct 25, 2024Fracture; Fracture
IT WAS REPORTED THAT TWO XIA 3 RODS FRACTURED APPROXIMATELY ONE YEAR POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. THE PATIENT WAS REPORTED TO HAVE NO CHANGES IN THEIR CONDITION AND NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT CAPTURES THE FIRST OF TWO XIA 3 RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533351 ↗MalfunctionOct 25, 2024Fracture; Fracture
IT WAS REPORTED THAT TWO XIA 3 RODS FRACTURED APPROXIMATELY ONE YEAR POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. THE PATIENT WAS REPORTED TO HAVE NO CHANGES IN THEIR CONDITION AND NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO XIA 3 RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533180 ↗InjuryOct 11, 2024Fracture; Fracture
IT WAS REPORTED THAT TWO XIA RODS FRACTURED APPROXIMATELY FOUR YEARS POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN UNKNOWN SERIOUS ADVERSE REACTION. THIS REPORT CAPTURES THE FIRST OF TWO XIA RODS.
Patient problems: Insufficient Information
MAUDE report 20428397 ↗InjuryOct 11, 2024Fracture; Fracture
IT WAS REPORTED THAT TWO XIA RODS FRACTURED APPROXIMATELY FOUR YEARS POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN UNKNOWN SERIOUS ADVERSE REACTION. THIS REPORT CAPTURES THE SECOND OF TWO XIA RODS.
Patient problems: Insufficient Information
MAUDE report 20428344 ↗InjuryJul 31, 2024Fracture; Fracture
IT WAS REPORTED VIA THE RUSSIAN HEALTH AUTHORITY THAT A PATIENT IS TO BE REVISED TO ADDRESS A XIA ROD FRACTURE WHICH WAS OBSERVED VIA IMAGING AT APPROXIMATELY 4.5 YEARS AFTER IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 19878177 ↗MalfunctionMay 8, 2024Fracture; Fracture
IT WAS REPORTED VIA THE RUSSIAN HEALTH AUTHORITY THAT A PATIENT EXPERIENCED PAIN APPROXIMATELY 26 MONTHS AFTER IMPLANTATION FOLLOWING A PHYSICAL ALTERCATION AND "HEAVY PHYSICAL LABOR." IMAGING REVEALED THE FRACTURE OF TWO XIA RODS. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Patient problems: Pain
MAUDE report 19274357 ↗MalfunctionMay 8, 2024Fracture; Fracture
IT WAS REPORTED VIA THE RUSSIAN HEALTH AUTHORITY THAT A PATIENT EXPERIENCED PAIN APPROXIMATELY 26 MONTHS AFTER IMPLANTATION FOLLOWING A PHYSICAL ALTERCATION AND "HEAVY PHYSICAL LABOR." IMAGING REVEALED THE FRACTURE OF TWO XIA RODS. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT CAPTURES THE SECOND OF TWO RODS.
Patient problems: Pain
MAUDE report 19274356 ↗InjuryApr 2, 2024Fracture; Fracture
IT WAS REPORTED VIA THE RUSSIAN HEALTH AUTHORITY THAT A PATIENT WAS HOSPITALIZED DUE TO CONSTRUCT INSTABILITY APPROXIMATELY 25 MONTHS AFTER IMPLANTATION AND IMAGING REVEALED THE FRACTURE OF TWO XIA RODS AT THE BASE OF THE CONSTRUCT. THE PATIENT HAS BEEN REVISED. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Patient problems: Inflammation
MAUDE report 19029702 ↗InjuryApr 2, 2024Fracture; Fracture
IT WAS REPORTED VIA THE RUSSIAN HEALTH AUTHORITY THAT A PATIENT WAS HOSPITALIZED DUE TO CONSTRUCT INSTABILITY APPROXIMATELY 25 MONTHS AFTER IMPLANTATION AND IMAGING REVEALED THE FRACTURE OF TWO XIA RODS AT THE BASE OF THE CONSTRUCT. THE PATIENT HAS BEEN REVISED. THIS REPORT CAPTURES THE SECOND OF TWO RODS.
Patient problems: Inflammation
MAUDE report 19029701 ↗MalfunctionFeb 23, 2024Fracture; Fracture
THE RUSSIAN HEALTH AUTHORITY REPORTED THAT A PATIENT REPORTED PAIN APPROXIMATELY THREE TO FOUR MONTHS POST-OPERATIVELY AND IMAGING REVEALED MIGRATION OF THE LEFT L4 SCREW AND FRACTURE OF TWO XIA RODS. IT IS UNKNOWN IF A REVISION SURGERY IS PLANNED. THIS REPORT CAPTURES THE SECOND OF THE TWO FRACTURED RODS.
Patient problems: Pain
MAUDE report 18773084 ↗InjuryJan 18, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WILL BE REVISED TO ADDRESS ONE FRACTURED ES2 STRAIGHT ROD AND TWO FRACTURED XIA TITANIUM RODS. THE PATIENT HAS REPORTED NUMBNESS AND WEAKNESS IN THEIR LOWER EXTREMITIES. THIS REPORT CAPTURES THE FIRST OF TWO XIA TITANIUM RODS.
Patient problems: Muscle Weakness/Atrophy; Numbness
MAUDE report 18540156 ↗InjuryJan 18, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WILL BE REVISED TO ADDRESS ONE FRACTURED ES2 STRAIGHT ROD AND TWO FRACTURED XIA TITANIUM RODS. THE PATIENT HAS REPORTED NUMBNESS AND WEAKNESS IN THEIR LOWER EXTREMITIES. THIS REPORT CAPTURES THE SECOND OF TWO XIA TITANIUM RODS.
Patient problems: Muscle Weakness/Atrophy; Numbness
MAUDE report 18540155 ↗InjuryJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR FRACTURED XIA 3 TITANIUM RODS AT THE T11 TO L1 LEVELS. THIS REPORT CAPTURES THE SECOND OF FOUR RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078472 ↗InjuryJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR FRACTURED XIA 3 TITANIUM RODS AT THE T11 TO L1 LEVELS. THIS REPORT CAPTURES THE THIRD OF FOUR RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078369 ↗InjuryJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR FRACTURED XIA 3 TITANIUM RODS AT THE T11 TO L1 LEVELS. THIS REPORT CAPTURES THE FOURTH OF FOUR RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078252 ↗InjuryJun 7, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR FRACTURED XIA 3 TITANIUM RODS AT THE T11 TO L1 LEVELS. THIS REPORT CAPTURES THE FIRST OF FOUR RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078249 ↗InjuryDec 16, 2021Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 2.5 YEARS POST-OPERATIVELY, AFTER HEARING A "POP" AND EXPERIENCING BACK PAIN, THE PATIENT PRESENTED WITH TWO FRACTURED XIA 3 RODS. THE PATIENT WAS REVISED AND THEIR CONSTRUCT WAS EXTENDED. THIS RECORD CAPTURES THE SECOND OF THE TWO RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 13022344 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.