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
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 ↗
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.
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