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
- TS 7000 1604788Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED1 recall4 reports
- TS 7500 1717023Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED1 recall1 report
- TS 7500 1704695Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED1 recall0 reports
- TS 7500 1854085Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED1 recall0 reports
- TS 7500 1854087Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED1 recall0 reports
- ADVANCED CONTROL I-BASE, DC 5803Mizuho Orthopedic Systems, Inc. · Table, Surgical With Orthopedic Accessories, Ac-Powered47 reports
- TRUMPF MEDICAL 1723633Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED43 reports
- TABLE, HANA, 110 V 6875Mizuho Orthopedic Systems, Inc. · Table, Surgical With Orthopedic Accessories, Ac-Powered2 deaths36 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page