CoRoent 5271308P2Recalls & reported problems
Nuvasive, Inc. · CoRoent Ant TLIF Ti, 7x11x30mm 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
- 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 00887517909176), received between Mar 11, 2021 and Mar 11, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Adverse Event Without Identified Device or Use Problem1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2021Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR SPINAL PROCEDURE TO ADDRESS STENOSIS AT THE L5-S. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED TO REMOVE A DISCOVERED HEMATOMA AT THE LEFT PEDICLE AT L5/S. DURING THE REVISION A METAL PIECE WAS DISCOVERED INSIDE THE PATIENT WHEN THE SURGEON MADE AN INCISION TO REMOVE THE HEMATOMA. THERE WAS NO DAMAGE OR ADVERSE EFFECTS TO PATIENT AS A RESULT OF THE RECOVERED FRAGMENT AND IT WAS RETRIEVED DURING THE REVISION.
Patient problems: Device Embedded In Tissue or Plaque; Hematoma
MAUDE report 11465414 ↗
Other Intervertebral fusion device with bone graft, thoracic devices
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- CoRoent 6130923P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- Cohere 6120308P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1181050P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1181055P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- TLX 5902826P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic1 report
- CoRoent 5281348P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic1 report
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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