CoRoent 6908855Recalls & reported problems
Nuvasive, Inc. · CoRoent® XL, 8x18x55mm · 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 00887517389718), received between Nov 7, 2016 and Mar 27, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- Bone Fracture(s)1
- Damage to Ligament(s)1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2018Fracture; Fracture
ON (B)(6) 2018 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE UTILIZING A CORONET XL INTERBODY DEVICE AND INSERTER. THE INTERBODY IMPLANT BECAME LODGED IN THE L3-L4 DISC SPACE. IMPACTION FORCE WAS APPLIED TO ADVANCE THE IMPLANT; THE CAGE FRACTURED INTO SEVERAL PIECES AT THE INSERTER/IMPLANT ENGAGEMENT. THE INSERTER PLUNGED ANTERIORLY DAMAGING THE SEGMENTAL ARTERY. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING WITH GAUZE PACKING, REMOVED THE PIECES OF CAGE AND COMPLETE THE PROCEDURE WITH NO COMPLICATION. ESTIMATED BLOOD LOSS IS NOT KNOWN; HOWEVER, BLOOD TRANSFUSION WAS REPORTEDLY NOT REQUIRED.
Patient problems: Bone Fracture(s); Perforation
MAUDE report 7375612 ↗MalfunctionNov 7, 2016Fracture; Fracture
A (B)(6) UNDERWENT A LATERAL PROCEDURE IN WHICH THREE 8MM INTERBODY DEVICES REPORTEDLY FRACTURED DURING IMPACTION. THE FOURTH CAGE WAS SUCCESFULLY PLACED BUT THE SURGEON DECIDED TO UPSIZE TO A 10MM CAGE DUE TO POSSIBLE ALL DAMAGE.
Patient problems: Damage to Ligament(s)
MAUDE report 6082721 ↗
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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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