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Hana Radiolucent Leg Spar Left 6875-360Recalls & 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 00842430106613), received between Aug 15, 2023 and Aug 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Fell” (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

  • Device Fell1
  • Fracture1

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.

  • MalfunctionAug 15, 2023Fracture; Device Fell; Fracture; Device Fell

    IT WAS REPORTED THAT WHILE TRANSFERRING PATIENT TO THE HANA TABLE THE SPAR WAS NOTICED TO BE NOT LOCKING PROPERLY. THE SPAR WAS STILL USED ON THE NON-OPERATIVE SIDE AND AT THE END OF SURGERY THE NON-OPERATIVE SPAR FELL TO THE FLOOR WHILE PATIENT'S LEG WAS STILL ATTACHED TO IT. STAFF REPORTED THAT THE PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17553214 ↗

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Sources and updates

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