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XIA 3 482311550Recalls & 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 04546540598783), received between Jan 19, 2021 and Jan 19, 2021 — classified as 1 malfunction.

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

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 19, 2021Fracture; Fracture

    IT WAS REPORTED THAT DURING A SCHEDULED REVISION, THE TULIP OF A XIA SERRATO POLYAXIAL SCREW BROKE OFF DURING SCREW REMOVAL. WHILE REPLACING THE SERRATO SCREW, THE TULIP OF A XIA 3 POLYAXIAL SCREW ALSO BROKE OFF. ALL PIECES OF THE FIRST SCREW WERE REMOVED; HOWEVER, THE SHAFT OF THE SECOND SCREW REMAINS IN THE PATIENT. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE XIA 3 SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11194656 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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