CoRoent 6081223Recalls & reported problems
Nuvasive, Inc. · CoRoent® Large MP, 12x9x23 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517283863), received between Oct 18, 2016 and Oct 18, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2016Patient-Device Incompatibility; Patient-Device Incompatibility
ON (B)(6) 2014 A FEMALE PATIENT UNDERWENT A CONSTRUCT IMPLANTATION AT L4-S1. ON (B)(6) 2016 NUVASIVE WAS NOTIFIED THE PATIENT SUFFERED AN ALLERGIC REACTION TO POLYETHERETHERKETONE (PEEK) THAT SUBSEQUENTLY RESULTED IN EXPLANTATION. THE PATIENT WAS REPORTED TO HAVE SUFFERED AN ANAPHYLACTIC REACTION APPROXIMATELY THREE WEEKS AFTER THE INDEX SURGERY.
Patient problems: Rash
MAUDE report 6038169 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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