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Cervical Management Base Unit 5979-1Recalls & reported problems

Mizuho Orthopedic Systems, Inc. · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842430106101), received between Jan 20, 2020 and Mar 31, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 16, 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: 0 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: 1 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

  • Device Slipped1
  • Loss of or Failure to Bond1
  • Use of Device Problem1
  • Use of Incorrect Control/Treatment Settings1

Patient problems

  • Insufficient Information1
  • Laceration(s)1
  • No Known Impact Or Consequence To Patient1
  • Paralysis1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 31, 2026Use of Device Problem

    TRIOS SPINAL TABLE WITH CMBU (CERVICAL MANAGEMENT BASE UNIT) WAS UTILIZED FOR AN ANTERIOR-POSTERIOR FLIP PROCEDURE ON AN 80-YEAR-OLD PATIENT WEIGHING APPROXIMATELY 75-85 LBS. THE HOSPITAL PERSONNEL HAD NOT PERFORMED THIS TECHNIQUE IN APPROXIMATELY 10 YEARS. PRIOR TO THE PROCEDURE, THE INITIAL REPORTER RECOMMENDED RESCHEDULING TO ALLOW FOR IN-SERVICE TRAINING; THIS RECOMMENDATION WAS DECLINED BY THE ASSISTANT SURGEON. DURING SETUP, THE CMBU WAS ATTACHED WITH DIRECTION FROM THE INITIAL REPORTER. THE SURGEON TIGHTENED THE CONNECTION OF MAYFIELD SKULL CLAMP WITH CMBU DESPITE NOT BEING RECOMMENDED BY THE INITIAL REPORTER. THE INITIAL REPORTER INTERVENED A SECOND TIME TO CORRECT IMPROPER POSITIONING OF THE CHEST PLATE AND HIP/THIGH COMBINATION COMPONENTS BEFORE COMPRESSION WAS ATTEMPTED. DUE TO THE PATIENT'S SMALL FRAME, ADEQUATE COMPRESSION COULD NOT BE ACHIEVED. WHEN THE FLAT TOP WAS RAISED IN AN ATTEMPT TO COMPENSATE, THE MAYFIELD SKULL CLAMP AND CMBU WERE IN A LOCKED STATE, RESULTING IN DISPLACEMENT OF THE SKULL PINS POSTERIORLY AND CAUSING LACERATIONS TO THE PATIENT. THE PROCEDURE WAS HALTED. THE SPINAL TABLE WAS REMOVED, AND THE PATIENT WAS SAFELY TRANSFERRED TO A BED. THE TABLE TO

    Patient problems: Laceration(s)

    MAUDE report 24745395 ↗
  • MalfunctionOct 11, 2022Use of Incorrect Control/Treatment Settings; Device Slipped; Use of Incorrect Control/Treatment Settings; Device Slipped

    IT WAS REPORTED THAT THERE WAS A STARBURST SLIP ON A CERVICAL MANAGEMENT BASE UNIT DURING SURGERY.

    Patient problems: Insufficient Information; Paralysis

    MAUDE report 15584333 ↗
  • MalfunctionJan 20, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    CUSTOMER REPORTED SOME BROKEN PARTS WERE EPOXIED BACK TOGETHER, BUT BROKE AGAIN ALONG THE GLUE LINE. THERE WAS NO INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9606609 ↗

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Sources and updates

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