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Cadence™ 10206206Recalls & reported problems

Ascension Orthopedics, Inc. · Cadence Insert Trial is used to verify proper implant placement and sizing. · Class 1

Data updated Oct 13, 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 10381780241010), received between Jul 27, 2022 and Jul 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • 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.

  • MalfunctionJul 27, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING AN ANKLE JOINT REPLACEMENT SURGERY, ONE OF THE PLASTIC RAILS OF THE CADENCE SIZE 2 INSERT TRIAL. 6MM THAT FIT INTO THE TIBIAL COMPONENT BROKE OFF AND WAS RECOVERED. THE DEVICE WAS HANDLED INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15113284 ↗

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Sources and updates

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