XIA 4 5 48144035Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540515193), received between Dec 15, 2025 and Dec 15, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 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
- Migration4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE THIRD OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812692 ↗InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE FOURTH OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812690 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812687 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812683 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.