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CoRoent 6990635Recalls & reported problems

Nuvasive, Inc. · CoRoent® XLT, 6x16x35mm · 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 00887517404299), received between Jan 20, 2023 and Jan 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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

  • Material Integrity Problem1

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.

  • MalfunctionJan 20, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS INITIALLY REPORTED THE IMPLANT "RUPTURED" UPON IMPACT WITH NO SURGICAL DELAY OR PATIENT IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED. HOWEVER, UPON EVALUATION OF THE DEVICE BY THE MANUFACTURER, IT WAS FOUND THE DEVICE WAS FRACTURED INTO MULTIPLE PIECES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16219168 ↗

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Sources and updates

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