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XIA 3 48238110Recalls & reported problems

Stryker Corporation · TI ALLOY RAD ROD · 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 07613154939732), received between Jul 10, 2018 and Jul 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

  • Migration1
  • Unintended Movement1

Patient problems

  • Failure of Implant1
  • Injury1

Recent adverse event reports

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

  • InjuryJul 10, 2018Unintended Movement; Migration; Migration

    IT WAS REPORTED THAT AFTER A LUMBAR SURGERY, BOTH RODS PULLED OUT OF THE TULIP AND MIGRATED SOUTH. THE PATIENT IS ANTICIPATED TO UNDERGO REVISION SURGERY. REVISION HAS NOT YET BEEN SCHEDULED.

    Patient problems: Failure of Implant; Injury

    MAUDE report 7674378 ↗

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