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CoRoent 5294402Recalls & reported problems

Nuvasive, Inc. · CoRoent Ant TLIF Ti, 9x14x40mm 12° · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517635228), received between Nov 11, 2022 and Nov 11, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED ON A LUMBAR INTERBODY CLINICAL STUDY THAT ON (B)(6) 2021 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4/5. ON (B)(6) 2022 IT WAS REPORTED THAT THERE WAS ONGOING RIGHT LOWER EXTREMITY RADICULAR PAIN TO THE ANKLE LEVEL. TREATMENT WAS GABAPENTIN & CELEBREX AND EPIDURAL STEROID INJECTION AT RIGHT L4-5 TRANSFORAMINAL.

    Patient problems: Pain

    MAUDE report 15780935 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.