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XIA 3 482317535Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

All models of XIA 3 (93)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540562333), received between Oct 17, 2017 and Oct 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1
  • Entrapment of Device1
  • Material Deformation1
  • Material Integrity Problem1

Patient problems

  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 17, 2017Break; Entrapment of Device; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

    IT WAS REPORTED THAT; WHEN THE SCREW WAS REMOVED DURING SURGERY, THE TULIP HEAD WAS STUCKED. THEREFORE, THE SCREW WAS REMOVED WITH KOCHEL. UPDATE 10/16/2017: WHEN THE SURGEON WAS PERFORMED FINAL TIGHTENING OF SCREW, THE ANTI TORQUE KEY CAME OFF FROM THE SCREW AND THE SCREW HOLE THREAD WAS BROKEN. THEREFORE, THE SCREW WAS REMOVED.

    Patient problems: No Information; No Known Impact Or Consequence To Patient

    MAUDE report 6954567 ↗

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Sources and updates

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