Skip to content

XIA 3 48230233Recalls & reported problems

Stryker Corporation · TRANSVERSE PROCESS HOOK, LEFT · 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 04546540560407), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    A PHYSICIAN REPORTED THAT WHILE ATTEMPTING TO INSTALL A XIA 3 TITANIUM TRANSVERSE PROCESS HOOK ON THE LEFT T11, THE PATIENT'S TRANSVERSE PROCESS BROKE. THE PHYSICIAN ALTERED THEIR SURGICAL PLAN AND THE OPERATION WAS COMPLETED SUCCESSFULLY USING A PEDICLE SCREW.

    Patient problems: Injury

    MAUDE report 9934170 ↗

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.