XIA 3 48230000Recalls & reported problems
Stryker Corporation · BLOCKER · Class 2 · Implant
Quick summary
This Stryker XIA 3 spinal fixation blocker has 193 reports, 100 injuries and no deaths. Many reports describe the blocker migrating out of place, fracturing, or loosening, and several describe revision surgery to remove or replace it, sometimes after infection. Reports rose from 4 in the prior 12 months to 15 in the most recent 12 months. 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
- 193
- Deaths reported
- 0
- Injuries reported
- 100
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 04546540560193), received between May 17, 2016 and Jun 8, 2026 — classified as 100 injuries, 93 malfunctions.
The most frequently reported specific device problem is “Migration” (81 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
- Migration81
- Fracture37
- Loose or Intermittent Connection32
- Mechanical Problem31
- Device Dislodged or Dislocated22
- Migration or Expulsion of Device22
- Appropriate Device Problem Term/Code Not Available15
- No Apparent Adverse Event15
Patient problems
- Injury72
- No Clinical Signs, Symptoms or Conditions49
- No Known Impact Or Consequence To Patient34
- Pain34
- No Consequences Or Impact To Patient23
- No Code Available16
- Insufficient Information12
- Unspecified Infection11
Recent adverse event reports
The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Migration
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE WEEKS POST-OPERATIVELY TO ADDRESS A MIGRATED XIA 3 BLOCKER. THE PATIENT REPORTED EXPERIENCING A "CLICKING" SOUND DURING MOVEMENT AND X-RAY IMAGING REVEALED THE MIGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437549 ↗InjuryMar 25, 2026Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT IMPLANTED WITH FOUR ES2 INTEGRATED BLADE SCREWS, FOUR XIA BLOCKERS, AND TWO MANTIS RODS EXPERIENCED AN INFECTION POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED AND THE DEVICES WERE EXPLANTED. THIS REPORT CAPTURES THE FOURTH OF FOUR XIA BLOCKERS.
Patient problems: Unspecified Infection
MAUDE report 24691088 ↗InjuryMar 25, 2026Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT IMPLANTED WITH FOUR ES2 INTEGRATED BLADE SCREWS, FOUR XIA BLOCKERS, AND TWO MANTIS RODS EXPERIENCED AN INFECTION POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED AND THE DEVICES WERE EXPLANTED. THIS REPORT CAPTURES THE THIRD OF FOUR XIA BLOCKERS.
Patient problems: Unspecified Infection
MAUDE report 24691087 ↗InjuryMar 25, 2026Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT IMPLANTED WITH FOUR ES2 INTEGRATED BLADE SCREWS, FOUR XIA BLOCKERS, AND TWO MANTIS RODS EXPERIENCED AN INFECTION POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED AND THE DEVICES WERE EXPLANTED. THIS REPORT CAPTURES THE FIRST OF FOUR XIA BLOCKERS.
Patient problems: Unspecified Infection
MAUDE report 24691086 ↗InjuryMar 25, 2026Insufficient Device Problem Information
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT IMPLANTED WITH FOUR ES2 INTEGRATED BLADE SCREWS, FOUR XIA BLOCKERS, AND TWO MANTIS RODS EXPERIENCED AN INFECTION POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED AND THE DEVICES WERE EXPLANTED. THIS REPORT CAPTURES THE SECOND OF FOUR XIA BLOCKERS.
Patient problems: Unspecified Infection
MAUDE report 24691085 ↗InjuryMar 9, 2026Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A "MECHANICAL FAILURE" BETWEEN AN ES2 ROD, AN ES2 INTEGRATED BLADE SCREW AND A XIA BLOCKER FIVE MONTHS POST-OPERATIVELY. UPON INSPECTION OF AN ADDITIONAL RETURNED XIA 3 BLOCKER, IT WAS OBSERVED THAT THIS BLOCKER ALSO SHOWS SIGNS OF MIGRATION. THIS REPORT CAPTURES THE SECOND RETURNED XIA BLOCKER.
Patient problems: Insufficient Information
MAUDE report 24544813 ↗InjuryNov 25, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647502 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487260 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487250 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487247 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS. THIS REPORT CAPTURES THE FIRST OF EIGHT BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487238 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487236 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487222 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487089 ↗InjuryNov 6, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS EIGHT MIGRATED MANTIS REDUX BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23487079 ↗InjurySep 25, 2025Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration
UPON INSPECTION OF AN ADDITIONAL RETURNED XIA 3 BLOCKER, IT WAS OBSERVED THAT THE BLOCKER SHOWED SIGNS OF MIGRATION. THIS REPORT CAPTURES THE FIRST OF TWO XIA BLOCKERS.
Patient problems: Insufficient Information
MAUDE report 23145098 ↗InjuryApr 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT IMAGING TAKEN APPROXIMATELY SIX MONTHS POST-OPERATIVELY REVEALED THAT THREE XIA 3 TITANIUM BLOCKERS MIGRATED. THE PATIENT THEN UNDERWENT REVISION SURGERY APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY. THIS RECORD CAPTURES THE SECOND OF THREE XIA BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21764092 ↗InjuryApr 3, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21764087 ↗InjuryFeb 5, 2025Migration; Migration
InjuryOct 3, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A MIGRATED XIA BLOCKER APPROXIMATELY EIGHT MONTHS AFTER IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20363984 ↗InjuryJun 28, 2023Migration; Migration
A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED XIA BLOCKERS. THE PATIENT REPORTED EXPERIENCING DISCOMFORT PRIOR TO REVISION. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED XIA BLOCKERS.
Patient problems: Pain
MAUDE report 17219472 ↗InjuryJun 28, 2023Migration; Migration
A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED XIA BLOCKERS. THE PATIENT REPORTED EXPERIENCING DISCOMFORT PRIOR TO REVISION. THIS REPORT CAPTURES THE FIRST OF TWO MIGRATED XIA BLOCKERS.
Patient problems: Pain
MAUDE report 17219305 ↗InjuryMay 10, 2023Migration; Migration
IT WAS REPORTED THAT 2 MONTHS AFTER IMPLANTATION, A RIGHT-SIDE XIA 3 BLOCKER AND A LEFT-SIDE XIA 3 BLOCKER MIGRATED, AND A LEFT-SIDE XIA 3 POLYAXIAL SCREW FRACTURED. THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER TO ADDRESS THE MIGRATED BLOCKERS AND FRACTURED SCREW. THE PATIENT EXPERIENCED MILDLY INCREASING LOW BACK AND PELVIC PAIN. THIS REPORT IS FOR THE LEFT-SIDE XIA 3 BLOCKER.
Patient problems: Pain
MAUDE report 16907214 ↗InjuryMay 10, 2023Migration; Migration
IT WAS REPORTED THAT 2 MONTHS AFTER IMPLANTATION, A RIGHT-SIDE XIA 3 BLOCKER AND A LEFT-SIDE XIA 3 BLOCKER MIGRATED, AND A LEFT-SIDE XIA 3 POLYAXIAL SCREW FRACTURED. THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER TO ADDRESS THE MIGRATED BLOCKERS AND FRACTURED SCREW. THE PATIENT EXPERIENCED MILDLY INCREASING LOW BACK AND PELVIC PAIN. THIS REPORT IS FOR THE RIGHT-SIDE XIA 3 BLOCKER.
Patient problems: Pain
MAUDE report 16907205 ↗MalfunctionFeb 3, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A XIA BLOCKER CRACKED INTRA-OPERATIVELY WHILE FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16299958 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
- YUKON OCT Spinal System 7601-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL60 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.