CoRoent 6080823P2Recalls & reported problems
Nuvasive, Inc. · CoRoent Large MP, 8x9x23mm 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517679604), received between Mar 27, 2018 and Mar 27, 2018 — classified as 1 death.
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
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2018 A PATIENT UNDERWENT A REVISION PROCEDURE OF ANOTHER MANUFACTURERS TRANSFORAMINAL LUMBAR INTERBODY FUSION. NUVASIVE CAGES WERE PLACED AT L5/S1 LEVELS WITHOUT ANY REPORTED PROBLEMS. DURING THE EXTENSION OF THE PREVIOUSLY PLACED POSTERIOR FIXATION, THE PATIENT'S BLOOD PRESSURE DECREASED. ROD INSERTION, SET SCREW TIGHTENING AND PLACEMENT OF TRANSVERSE CONNECTORS WAS PERFORMED AND PATIENT WAS CLOSED. CARDIAC MASSAGE AND FIRST AID TREATMENT WAS PERFORMED. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND LATER EXPIRED. THE CAUSE OF THE PATIENT'S DEMISE IS UNKNOWN AT THIS TIME.
Patient problems: Death
MAUDE report 7375934 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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