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CoRoent 6081228Recalls & reported problems

Nuvasive, Inc. · CoRoent® Large MP, 12x9x28 8° · Class 2 · Implant

All models of CoRoent (64)

Data updated Oct 16, 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 00887517283887), received between Dec 13, 2022 and Dec 13, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

  • MalfunctionDec 13, 2022Fracture; Fracture

    THE CAGE WAS IMPLANTED ACCORDING TO THE SURGICAL INSTRUCTIONS USING THE INSERT AND ROTATE TECHNIQUE. WHEN THE CAGE WAS ROTATED TO ITS FINAL POSITION, IT BROKE INTO SEVERAL FRAGMENTS. ALL FRAGMENTS HAVE BEEN REMOVED. THE PATIENT WAS THEN TREATED WITH NEW CAGES AND THE CASE WAS FINALIZED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15968967 ↗

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Sources and updates

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