Skip to content

XIA 3 482319540Recalls & 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 04546540598677), received between Aug 20, 2018 and Aug 20, 2018 — classified as 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
  • Detachment of Device or Device Component1

Patient problems

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

Recent adverse event reports

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

  • MalfunctionAug 20, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING FINE ADJUSTMENT OF THE SCREW HEAD WITH INTRAOPERATIVE MONO DRIVER, THE SCREW HEAD BROKE. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

    MAUDE report 7796630 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

All Orthosis, spondylolisthesis spinal fixation devices →

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