Cohere 8221055P2Recalls & reported problems
Nuvasive, Inc. · COHERE XLW, 10x22x55mm 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 00887517983244), received between Oct 23, 2024 and Oct 23, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE AMS IN XLIF STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L4/5. DURING THE PROCEDURE AN INCIDENTAL DUROTOMY OCCURRED WITH DECOMPRESSION OF CENTRAL CANAL AND TRAVERSING NERVE ROOT. SMALL PIECE OF LIGAMENTUM FLAVUM WAS LEFT ON TOP OF CSF LEAK. NO LEAK NOTED SO SQUARE PATCH OF TACHOSIL PLACED OVER FLAVUM AND DURA. TISSEAL THEN APPLIED OVER DURA. NO ADDITIONAL ISSUES REPORTED.
Patient problems: Laceration(s)
MAUDE report 20519097 ↗
Other Intervertebral fusion device with bone graft, thoracic devices
- Modulus 1775850Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic37 reports
- Modulus 1225255P2Nuvasive, Inc. · Intervertebral fusion device with bone graft, thoracic2 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page