Cohere 6120308P2Recalls & reported problems
Nuvasive, Inc. · COHERE TLIF-O, 12x10x30mm 8° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195377034984), received between Feb 15, 2022 and Apr 18, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration” (2 reports).
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
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2022Migration; Migration
ON (B)(6) 2021 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE ON L5-S1 OF THE SPINE AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. DURING THE PATIENTS SEVEN WEEK FOLLOW UP APPOINTMENT THE PATIENT REPORTED THEY WERE HAVING ISSUES WITH RIGHT LEG NERVE PAIN ALTHOUGH THE STATED THEY STILL FELT MUCH BETTER THAN BEFORE THE INITIAL PROCEDURE. THE PATIENTS STATUS CONTINUED TO BE MONITORED. DURING A THREE MONTH FOLLOW UP APPOINTMENT THE PATIENT REPORTED THEY CONTINUED TO HAVE DISTAL RIGHT L5 SYMPTOMS. WHILE SHE STATED THE SYMPTOMS WERE CONTINUING TO IMPROVE SHE STATED THERE WAS AN INCIDENT WHERE SHE LOCKED HERSELF OUT OF HER HOUSE AND HAD TO CRAWL THROUGH HER WINDOW. DURING THE PROCESS SOMETHING OCCURRED WHICH SHE SAID AGGRAVATED HER SYMPTOMS AND THE PATIENT BEGAN ATTENDING PHYSICAL THERAPY TO HELP HER PAIN. ON A UNKNOWN DATE IT EARLY (B)(6) IT WAS DISCOVERED THE IMPLANTED CAGE AT THE L5-S1 LEVEL HAD MIGRATED. ON (B)(6) A REVISION OCCURRED WHERE THE IMPLANT WAS EXPLANTED. THE PATIENT IS DOING WELL POST REVISION.
Patient problems: Pain
MAUDE report 14136492 ↗MalfunctionFeb 15, 2022Migration; Migration
ON (B)(6) 2021 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S1. ON (B)(6) 2022 IT WAS DISCOVERED VIA RADIOGRAPHS THAT THE CAGE MIGRATED. NO PATIENT INJURY WAS REPORTED AND NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13538371 ↗
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
- 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
- IDENTITI 100-06185510-SAlphatec Spine, 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