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WILSON PLUS UNIVERSAL W/TEMPUR PADS 5319GRecalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842430105104), received between Jun 1, 2023 and Jun 1, 2023 — classified as 1 malfunction.

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

  • Collapse1
  • Detachment of Device or Device Component1

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.

  • MalfunctionJun 1, 2023Collapse; Detachment of Device or Device Component; Collapse; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A LUMBAR DISECTOMY, THE RIGHT SIDE RAIL OF WILSON FRAME CAME LOOSE AND COLLAPSED. THE PATIENT WAS CAUGHT/SECURED SO AS TO AVOID THE FALL AND WAS REPORTED TO BE OKAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17044538 ↗

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Sources and updates

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