XIA 4.5 System - XIA CTRecalls & reported problems across all models
Stryker Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 8 models of XIA 4.5 System - XIA CT by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2016 and Jun 1, 2023 — classified as 21 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Migration” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported XIA 4.5 System - XIA CT problems
Device problems
- Migration16
- Migration or Expulsion of Device13
- Device Slipped8
- Noise, Audible7
- Unintended Movement6
- Detachment of Device or Device Component2
- Material Separation2
- Mechanical Problem2
Patient problems
- Injury14
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient13
- No Clinical Signs, Symptoms or Conditions7
- No Code Available4
- Numbness2
- Pain2
- Failure of Implant1
XIA 4.5 System - XIA CT models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIA 4.5 System - XIA CT 48850000Orthosis, spondylolisthesis spinal fixation27 reports
- XIA 4.5 System - XIA CT 488515535APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- XIA 4.5 System - XIA CT 488515030APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- XIA 4.5 System - XIA CT 488516535APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- XIA 4.5 System - XIA CT 488515035Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- XIA 4.5 System - XIA CT 488514535ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA 4.5 System - XIA CT 488525030Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- XIA 4.5 System - XIA CT 488526530APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
Recent XIA 4.5 System - XIA CT adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 3, 2020Material Separation; Material Separation
A PHYSICIAN REPORTED THAT THE, "HEAD POPPED OFF THE SHANK," OF A XIA CT POLYAXIAL SCREW APPROXIMATELY FIFTEEN-MONTHS POST-OPERATIVELY. THE PATIENT HAS RECEIVED MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 10489416 ↗InjuryJun 5, 2020Fracture; Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE AND A XIA CT POLYAXIAL CORTICAL SCREW, IMPLANTED AT L5-S1, FRACTURED POST-OPERATIVELY. FUSION WAS NOT ACHIEVED. REVISION SURGERY WILL OCCUR TO REPLACE DEVICES. THIS REPORT CAPTURES THE SCREW.
Patient problems: Injury
MAUDE report 10125323 ↗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 ↗InjuryDec 5, 2019Migration; Migration
PATIENT HEARD A CLICKING NOISE EVERY TIME THEY TWISTED OR STOOD UP 30 DAYS POST-OP. PHYSICIAN REPORTED THAT A XIA CT POLYAXIAL CORTICAL SCREW 4.5 X 35 MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED.
Patient problems: Injury
MAUDE report 9418945 ↗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 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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