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XIA 3 482314540Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

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 04546540561923), received between Oct 21, 2016 and Oct 21, 2016 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1
  • Mechanical Problem1

Patient problems

  • Bone Fracture(s)1
  • No Information1

Recent adverse event reports

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

  • MalfunctionOct 21, 2016Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED THAT SURGEON REPORTED THE CASE OF L1 FRACTURE WHERE 4.5 & 5.5 SCREWS HAVE BEEN INSERTED .WHEN APPLIED THE ANTI TURK WITH TIGHTENING OF THE SET SCREW, THE HEAD WAS BROKEN AS IN THE ATTACHED IMAGES. DURING TIGHTENING OF THE SET SCREW IT WAS EASY AND WENT IN CORRECT DIRECTION. THE BROKEN SCREW HAS BEEN REMOVED.

    Patient problems: Bone Fracture(s); No Information

    MAUDE report 6049029 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.