Cohere 8181250P2Recalls & reported problems
Nuvasive, Inc. · COHERE XL, 12x18x50mm 10° · Class 2 · Implant
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 00887517982827), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 injury.
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
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON AN UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR SPINAL PROCEDURE AT L3-L5 LEVELS WITHOUT ANY REPORTED ISSUES. POST-OPERATIVE, THE PATIENT WAS REPORTED TO HAVE LOW OXYGEN SATURATION AND SHORTNESS OF BREATH. AS PER REPORTER, RADIOGRAPHS CONFIRMED SUBACUTE PULMONARY EMBOLUS. PATIENT WAS TREATED WITH MEDICATIONS.
Patient problems: Pulmonary Embolism
MAUDE report 9734660 ↗
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- TLX 5902826P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic1 report
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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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