XIA 4.5 System - XIA CT 48850000Recalls & reported problems
Stryker Corporation · Blocker · Class 2 · Implant
All models of XIA 4.5 System - XIA CT (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker XIA 4.5 spinal blocker is a small implant used in spine fixation surgery to hold vertebrae steady. The 27 adverse event reports mostly describe the blocker shifting out of position after surgery, sometimes making a clicking noise when the patient moved, and in several cases the implant was not tight enough, which the reports say let the spinal rods move and led to a second operation. There are 14 injuries and no deaths reported. No recalls name this device.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327132526), received between Aug 9, 2016 and Jun 1, 2023 — classified as 14 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Migration11
- Migration or Expulsion of Device11
- Noise, Audible7
- Device Slipped6
- Unintended Movement4
- Mechanical Problem2
- Crack1
- Loose or Intermittent Connection1
Patient problems
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient10
- Injury8
- No Clinical Signs, Symptoms or Conditions6
- No Code Available3
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST-OPERATIVELY 4 XIA BLOCKERS MIGRATED ON BOTH SIDES OF A ONE-LEVEL CONSTRUCT. THE PATIENT WAS REVISED. THIS REPORT IS FOR THE FOURTH OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17041177 ↗InjuryJun 1, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST-OPERATIVELY 4 XIA BLOCKERS MIGRATED ON BOTH SIDES OF A ONE-LEVEL CONSTRUCT. THE PATIENT WAS REVISED. THIS REPORT IS FOR THE FIRST OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17041066 ↗InjuryJun 1, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST-OPERATIVELY 4 XIA BLOCKERS MIGRATED ON BOTH SIDES OF A ONE-LEVEL CONSTRUCT. THE PATIENT WAS REVISED. THIS REPORT IS FOR THE THIRD OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17041063 ↗InjuryJun 1, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST-OPERATIVELY 4 XIA BLOCKERS MIGRATED ON BOTH SIDES OF A ONE-LEVEL CONSTRUCT. THE PATIENT WAS REVISED. THIS REPORT IS FOR THE SECOND OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17041062 ↗InjuryMay 25, 2021Migration; Migration
A PHYSICIAN REPORTED MIGRATION OF TWO XIA CT BLOCKERS AND ONE TRITANIUM PL CAGE. THE PATIENT WAS REVISED APPROXIMATELY EIGHT WEEKS AFTER IMPLANTATION. THIS REPORT CAPTURES THE SECOND OF TWO XIA CT BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11880946 ↗InjuryMay 25, 2021Migration; Migration
A PHYSICIAN REPORTED MIGRATION OF TWO XIA 4.5 BLOCKERS AND ONE TRITANIUM PL CAGE. THE PATIENT WAS REVISED APPROXIMATELY EIGHT WEEKS AFTER IMPLANTATION. ALL COMPONENTS OF THE CONSTRUCT WERE RETURNED. ANALYSIS OF THE ADDITIONAL FOUR XIA 4.5 BLOCKERS WHICH WERE RETURNED INDICATES THAT ALL SIX BLOCKERS IN THE CONSTRUCT WERE NOT APPROPRIATELY SECURED AND THEREFORE CONTRIBUTED TO THE MIGRATION OF THE RODS. THIS REPORT CAPTURES THE FIRST OF SIX XIA 4.5 BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11880865 ↗InjuryDec 5, 2019Migration; Migration
PATIENT HEARD A CLICKING NOISE EVERY TIME THEY TWISTED OR STOOD UP 30 DAYS POST-OP. PHYSICIAN REPORTED THAT FOUR XIA CT BLOCKER MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE FOURTH BLOCKER.
Patient problems: Injury
MAUDE report 9419503 ↗InjuryDec 5, 2019Migration; Migration
PATIENT HEARD A CLICKING NOISE EVERY TIME THEY TWISTED OR STOOD UP 30 DAYS POST-OP. PHYSICIAN REPORTED THAT FOUR XIA CT BLOCKER MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE SECOND BLOCKER.
Patient problems: Injury
MAUDE report 9419502 ↗InjuryDec 5, 2019Migration; Migration
PATIENT HEARD A CLICKING NOISE EVERY TIME THEY TWISTED OR STOOD UP 30 DAYS POST-OP. PHYSICIAN REPORTED THAT FOUR XIA CT BLOCKER MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE THIRD BLOCKER.
Patient problems: Injury
MAUDE report 9419497 ↗InjuryDec 5, 2019Migration; Migration
PATIENT HEARD A CLICKING NOISE EVERY TIME THEY TWISTED OR STOOD UP 30 DAYS POST-OP. PHYSICIAN REPORTED THAT FOUR XIA CT BLOCKER MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE FIRST BLOCKER.
Patient problems: Injury
MAUDE report 9419495 ↗InjurySep 27, 2019Migration or Expulsion of Device; Migration; Migration
A PHYSICIAN REPORTED THAT A XIA CT BLOCKER MIGRATED FROM S1 APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY. THE PHYSICIAN PLANS TO PERFORM AN ALIF AT L5 TO S1 BUT IT IS NOT KNOWN IF THEY INTEND TO REVISE THE POSTERIOR CONSTRUCT DURING THIS SURGERY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9131813 ↗MalfunctionMay 2, 2019Device Slipped; Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING A PRE-SCHEDULED FUSION EXTENSION SURGERY, THE SURGEON NOTED THE BLOCKERS WERE ALREADY LOOSE. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573242 ↗MalfunctionMay 2, 2019Device Slipped; Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING A PRE-SCHEDULED FUSION EXTENSION SURGERY, THE SURGEON NOTED THE BLOCKERS WERE ALREADY LOOSE. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573239 ↗MalfunctionMay 2, 2019Device Slipped; Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING A PRE-SCHEDULED FUSION EXTENSION SURGERY, THE SURGEON NOTED THE BLOCKERS WERE ALREADY LOOSE. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573238 ↗MalfunctionMay 2, 2019Loose or Intermittent Connection; Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING A PRE-SCHEDULED FUSION EXTENSION SURGERY, THE SURGEON NOTED THE BLOCKERS WERE ALREADY LOOSE. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573237 ↗MalfunctionApr 8, 2019Crack; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING FINAL TIGHTENING, THE SURGEON NOTICED THAT THE TORQUE WRENCH KEPT POPPING OUT OF THE BLOCKER. UPON FURTHER EXAMINATION, THE SURGEON NOTICED THAT THE BLOCKER HAD CRACKED. A SURGICAL DELAY OF 45 SECONDS WAS REPORTED. THE SURGERY WAS COMPLETED REPLACING CRACKED BLOCKER WITH A NEW ONE. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8493333 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Noise, Audible
IT WAS REPORTED THAT; PATIENT COMPLAINS OF 'SQUEAKING' COMING FROM HIS LOWER BACK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6775579 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Noise, Audible
IT WAS REPORTED THAT; PATIENT COMPLAINS OF 'SQUEAKING' COMING FROM HIS LOWER BACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6775577 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Noise, Audible
IT WAS REPORTED THAT; PATIENT COMPLAINS OF 'SQUEAKING' COMING FROM HIS LOWER BACK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6775568 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Noise, Audible
IT WAS REPORTED THAT; PATIENT COMPLAINS OF 'SQUEAKING' COMING FROM HIS LOWER BACK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6775567 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Noise, Audible
IT WAS REPORTED THAT; PATIENT COMPLAINS OF 'SQUEAKING' COMING FROM HIS LOWER BACK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6775566 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Noise, Audible
IT WAS REPORTED THAT; PATIENT COMPLAINS OF 'SQUEAKING' COMING FROM HIS LOWER BACK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6775565 ↗InjuryAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Device Slipped
IT WAS REPORTED THAT; REVISION L3-L5 AFTER RODS SLIPPED OUT OF SCREWS.
Patient problems: Injury; No Code Available
MAUDE report 6775530 ↗MalfunctionAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device; Device Slipped
IT WAS REPORTED THAT; REVISION L3-L5 AFTER RODS SLIPPED OUT OF SCREWS.
Patient problems: Failure of Implant; Injury; No Code Available
MAUDE report 6775529 ↗MalfunctionDec 27, 2016Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device
IT IA REPORTED THAT THE PATIENT IS BEING REVISED DUE TO A BLOCKER THAT BACKED OUT OF A TULIP HEAD. THE ISSUE WAS NOTICED BY THE SURGEON ON A REGULAR POST OP VISIT. THE SURGEON INDICATED THE PATIENT HEARD SQUEAKING OF THE HARDWARE.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 6205911 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 reports
- EXPEDIUM VERSE 199721540Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation24 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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