CoRoent 5191304P2Recalls & reported problems
Nuvasive, Inc. · CoRoent Ant TLIF PEEK, 9x11x30mm 4° · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517897923), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
- Migration or Expulsion of Device1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE (1) LEVEL POSTERIOR FIXATION PROCEDURE AT L4/5 USING AN ANTERIOR TLIF INTERBODY CAGE AND POSTERIOR FIXATION. SUBSEQUENTLY, ON AN UNKNOWN DATE, THE PATIENT REPORTED SYMPTOMS OF PAIN. UPON EXAMINATION, IT WAS IDENTIFIED THAT THE INTERBODY CAGE HAD MIGRATED LATERALLY AND WAS OUTSIDE OF THE DISC SPACE. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TEN (10) WEEKS AFTER THE INITIAL SURGERY TO REMOVE THE MIGRATED DEVICE AND EXTEND THE FIXATION CONSTRUCT FROM L3 TO S2. NO FURTHER PATIENT IMPACT WAS REPORTED.
Patient problems: Pain
MAUDE report 14640405 ↗
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- 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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