CoRoent 5271300P2Recalls & reported problems
Nuvasive, Inc. · CoRoent Ant TLIF Ti, 7x11x30mm 0° · 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 00887517909138), received between Feb 20, 2023 and Feb 20, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR FIXATION PROCEDURE ON AN UNKNOWN DATE. THE PATIENT REPORTED NO ALLERGIC REACTION IN RELATION TO THE INITIAL FIXATION. THE PATIENT THEN UNDERWENT A SECOND PROCEDURE TO IMPLANT AN INTERBODY AND ADDITIONAL POSTERIOR FIXATION. SUBSEQUENTLY, IT WAS NOTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION APPROXIMATELY SEVEN (7) WEEKS LATER AND WAS BEING TREATED BY ANOTHER DEPARTMENT. INFORMATION REGARDING THE TYPE OF ALLERGY, SYMPTOMS, OR OTHER IMPLANTED MATERIALS WAS REQUESTED BUT WAS NOT AVAILABLE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16406217 ↗
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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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