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CoRoent 6200450Recalls & reported problems

Nuvasive, Inc. · CoRoent® XL-H, 4x22x50mm 20° · 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 00887517295415), received between Mar 29, 2019 and Mar 29, 2019 — 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

  • Post Operative Wound Infection1
  • Pulmonary Embolism1

Recent adverse event reports

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

  • InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON MARCH 2, 2019, THE FOLLOWING EVENT WAS REPORTED AT A PHYSICIAN CONFERENCE ON A COROENT XL-H. CASE 2: ON AN UNKNOWN DATE A PROCEDURE USING COROENT XL-H WAS PERFORMED. POST PROCEDURE, A SYMPTOMATIC PULMONARY EMBOLISM AND BACK SIDE DEEP INFECTION OCCURRED.

    Patient problems: Post Operative Wound Infection; Pulmonary Embolism

    MAUDE report 8465483 ↗

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