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ASSY, SWIVEL ADAPTER 5979-323Recalls & reported problems

Mizuho Orthopedic Systems, Inc. · Class 1

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842430113888), received between Jun 16, 2020 and Feb 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Separation1
  • Unintended Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Numbness1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 12, 2025Material Separation; Material Separation

    DURING A SUPINE ACDF PROCEDURE ON A TRIOS TABLE, THE LOCKING KNOB OF THE SWIVEL ADAPTER THAT INTERFACES WITH THE SKULL CLAMP WAS DETACHED, CAUSING THE PATIENT'S HEAD TO DROP A FEW INCHES ON THE IMAGING TOP PAD. NO INJURY REPORTED TO THE PATIENT. NEUROMONITORING INDICATED EVERYTHING WAS NORMAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21366381 ↗
  • InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

    IT WAS REPORTED THE ALUMINUM SWIVEL ADAPTOR BALL JOINT OF THE CERVICAL MANAGEMENT BASE UNIT FAILED DURING SURGERY, ALLOWING THE PATIENT'S HEAD TO MOVE, POSSIBLY CAUSING INJURY. THE PATIENT COMPLAINED OF PAIN AND NUMBNESS AFTER SURGERY AND WAS RE-HOSPITALIZED.

    Patient problems: Numbness; Pain

    MAUDE report 10159320 ↗

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Sources and updates

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