Cohere 4119305P2Recalls & reported problems
Nuvasive, Inc. · Cohere TLIF-A, 11x9x30mm 15° · Class 2 · Implant
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 00195377029515), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Break; Break
IT WAS REPORTED THAT WHILE UNDERGOING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE THE INTERBODY SPACER BROKE DURING INSERTION. NO INFORMATION WAS PROVIDED ON HOW THE DEVICE BROKE. THE DEVICE WAS ABLE TO BE RETRIEVED WITH NO REPORTED PATIENT IMPACT AN NO FURTHER IMPACT TO THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904865 ↗
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- Modulus 1181050P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
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- 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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