CoRoent 6308850Recalls & reported problems
Nuvasive, Inc. · CoRoent® XL+, 8x18x50mm 10° · 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 00887517305473), received between Jan 5, 2016 and Jan 5, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Bowel Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2016Insufficient Device Problem Information
ON (B)(6) 2015 A FEMALE PATIENT UNDERWENT A XLIF PROCEDURE ON THE RIGHT SIDE WITH NO PROBLEMS OR ISSUES NOTED AT TIME OF SURGERY. POST-OPERATIVELY THE PATIENT COMPLAINED OF ABDOMINAL DISCOMFORT FOR WHICH A LAPAROTOMY WAS PERFORMED. DURING THE PROCEDURE A 5MM HOLE WAS DISCOVERED IN THE ASCENDING COLON WHICH WAS CLEANSED AND SUTURED. PATIENT CONDITION IMPROVED. NO ADDITIONAL PATIENT INJURY REPORTED.
Patient problems: Bowel Perforation
MAUDE report 5345741 ↗
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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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