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XIA 3 482318560Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540598622), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Material Separation1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryOct 3, 2019Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE TULIPS OF TWO XIA 3 TITANIUM POLYAXIAL SCREW DISENGAGED TWO DAYS POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS RECORD CAPTURES THE FIRST SCREW.

    Patient problems: Injury

    MAUDE report 9152336 ↗

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