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XIA 3 482315540Recalls & reported problems

Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant

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 04546540562043), received between Apr 11, 2016 and Sep 29, 2017 — classified as 1 injury, 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
  • Burst Container or Vessel1
  • Detachment of Device or Device Component1
  • Fracture1
  • Material Integrity Problem1
  • Mechanical Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Injury1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjurySep 29, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

    IT WAS REPORTED THAT; AN INCIDENT OF SCREW BREAKAGE IN PATIENTS' BODY AFTER SURGERY. SCREW IS FOUND BROKEN, THEN REVISION SURGERY IS DONE, BUT THE BROKEN PART CANNOT BE RETRIEVED (STILL IN PATIENT BODY).

    Patient problems: Device Embedded In Tissue or Plaque; Injury

    MAUDE report 6904716 ↗
  • MalfunctionApr 11, 2016Mechanical Problem; Detachment of Device or Device Component; Burst Container or Vessel; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE SURGEON WENT TO REMOVE THE L5 SCREW ON THE RIGHT AND WHILE REMOVING IT WITH THE CORRECT DRIVER THE TULIP POPPED OFF. HE WAS ABLE TO REMOVE THE BONE SCREW WITH THE QUICK OUT DRIVER THOUGH. NO ADDITIONAL TIME WAS ADDED TO THE CASE AND THE PATIENT WAS NOT EFFECTED.

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

    MAUDE report 5567918 ↗

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