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ADVANCED CONTROL I-BASE, DC, JAPAN 5803JRecalls & 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 00842430107016), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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

  • Unintended Movement1

Patient problems

  • Fall1

Recent adverse event reports

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

  • InjuryDec 15, 2020Unintended Movement; Unintended Movement

    IT WAS REPORTED, DURING SPINAL SURGERY, THE ORTHOPEDIC DOCTOR INSTRUCTED THE ANESTHESIOLOGY TRAINEE TO TILT ACTION. HOWEVER, THE HAND PENDANT DID NOT RESPOND BECAUSE THE 180 DEGREE ROTATION LOCK BLUE HANDLE (HEAD SIDE) WAS UNLOCKED FOR SOME REASON. WHILE THE ANESTHESIOLOGY TRAINEE SUSPECTED A PROBLEM AND WAS OPERATING VARIOUS OPERATIONS, HE PRESSED THE ROTATION SAFETY LOCK SWITCH (LEG SIDE). AT THAT MOMENT, THE 180 DEGREE ROTATION LOCK WAS COMPLETELY UNLOCKED, THE TABLE ROTATED UNDER THE PATIENT'S OWN WEIGHT AND THE PATIENT FELL FROM HEAD TO THE FLOOR.

    Patient problems: Fall

    MAUDE report 11011169 ↗

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Sources and updates

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