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XIA 3 482365550Recalls & reported problems

Stryker Corporation · UNIPLANAR REDUCTION SCREW · Class 2 · Implant

All models of XIA 3 (93)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540602039), received between May 11, 2016 and Nov 10, 2022 — classified as 1 injury, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Dislodged or Dislocated1
  • Material Deformation1
  • Material Integrity Problem1
  • Material Separation1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 10, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE TULIP OF A XIA 3 UNIPLANAR REDUCTION SCREW BECAME DISENGAGED. THE PATIENT WAS IMPLANTED AND STILL IN HOSPITAL FOLLOWING THE INITIAL SURGERY WHEN THEY REPORTED EXPERIENCING PAIN. IMAGING WAS PERFORMED AND IDENTIFIED A DISENGAGED TULIP. REVISION SURGERY WAS PERFORMED.

    Patient problems: Pain

    MAUDE report 15776725 ↗
  • MalfunctionMay 11, 2016Material Separation; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

    IT WAS REPORTED THAT; THE 5.5 UNIPLANAR REDUCTION TULIP, SEPARATED FROM THE THREAD SHAFT DURING REMOVAL OF THE TEMPORARY ROD. UPDATE (20-APRIL-2016): THE TEMPORARY ROD HOLDS EVERYTHING IN POSITION AND HELPS WHEN PUTTING A ROD IN ONE SIDE. THE TEMPORARY ROD IS A SMALL ROD (6IN) PUT IN ONE SIDE AND THE PERMANENT ROD IS PLACED ON OTHER SIDE. IT ACTS LIKE A BRACE FOR WHEN PUTTING THE ROD ON THE ADJACENT SIDE. IT IS IMPLANTED TEMPORARILY FOR 15-20MIN AND ONCE CORRECTION IS DONE THEY REMOVE THE TEMP ROD AND REPLACE WITH PERMANENT ROD. ALL HAPPENS DURING THE SAME PROCEDURE. ISSUE WAS NOTICED DURING REMOVAL OF THE TEMP ROD. TULIP HEAD WAS OFF THE THREADED PART WAS STILL IN THE BODY AND THEY TOOK THE DRIVER AND TOOK IT OUT. NO DELAY. NO ADVERSE CONSEQUENCES.

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

    MAUDE report 5648315 ↗

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Sources and updates

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