Skip to content

WILSON PLUS RADIOLUCENT FRAME SPINE 5321GRecalls & reported problems

Mizuho Orthopedic Systems, Inc. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00842430104459), received between Aug 31, 2022 and Aug 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (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 18, 2026.

Most reported problems

Device problems

  • Device Handling Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Blister1
  • Bruise/Contusion1

Recent adverse event reports

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

  • InjuryAug 31, 2022Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

    IT WAS REPORTED THAT THE PADS ON THEIR WILSON FRAME WERE INSTALLED IN WRONG DIRECTION. CUSTOMER STATED THEY PLACED PATIENT ONTO WILSON FRAME WHERE PART OF THE PATIENT'S CHEST WAS SITTING ON NO PADDING FOR THE DURATION OF SURGERY WHICH WAS APPROXIMATELY 5 HOURS. WHEN THEY REMOVED PATIENT THEY DISCOVERED BLISTERS AND BRUISING. THEY TREATED PATIENT BY WRAPPING THE AFFECTED AREA.

    Patient problems: Blister; Bruise/Contusion

    MAUDE report 15328666 ↗

Other Table, Surgical With Orthopedic Accessories, Ac-Powered devices

All Table, Surgical With Orthopedic Accessories, Ac-Powered devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page