CoRoent 6980855Recalls & reported problems
Nuvasive, Inc. · CoRoent® XL, 8x18x55mm 10° · Class 2 · Implant
All models of CoRoent (64)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517403216), received between Aug 25, 2022 and Dec 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A SPINAL PROCEDURE AN INTERVERTEBRAL SPACER BROKE NEAR THE INSERTER CONNECTION WHEN IT WAS BEING IMPLANTED INTO THE PATIENT. THE BROKEN DEVICE WAS ABLE TO BE RETRIEVED. IT WAS REPORTED THAT THE PROCEDURE TIME WAS EXTENDED TO REMOVE THE BROKEN DEVICE. NO PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887966 ↗MalfunctionAug 25, 2022Material Fragmentation; Material Fragmentation
COROENT® XL, 8X18X55MM 10° (PN 6980855) BREAKS INTRAOP IN AN XLIF CASE 2 DAYS AGO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15294212 ↗
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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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