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CoRoent 6981045Recalls & reported problems

Nuvasive, Inc. · CoRoent® XL, 10x18x45mm 10° · 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 00887517403247), received between Sep 1, 2023 and Sep 1, 2023 — 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.

  • MalfunctionSep 1, 2023Fracture; Fracture

    ON (B)(6) 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE WHILE IMPACTING A VERTEBRAL SPACER INTO THE DISC SPACE THE IMPLANT FRACTURED AT THE INSERTER ENGAGEMENT POINT. ALL PIECES OF THE FRACTURED IMPLANT WERE REMOVED FROM THE PATIENT AND A SECOND IMPLANT WAS UTILIZED. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17672418 ↗

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Sources and updates

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