Cohere 6120254P2Recalls & reported problems
Nuvasive, Inc. · COHERE TLIF-O, 12x10x25mm 4° · 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 00887517020789), received between Mar 30, 2022 and Mar 30, 2022 — 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
- 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.
InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT WAS CREATED FROM A LUMBAR INTERBODY CLINICAL REVIEW THAT A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5/S1 ON (B)(6) 2022. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS AN INCIDENTAL DUROTOMY INTRAOPERATIVELY DUE TO THE DEGREE OF STENOSIS. DUROTOMY OCCURRED POSTERIORLY AT L5/S1 AND WAS REPAIRED WITH DURAGEN AND DURASEAL.
Patient problems: Laceration(s)
MAUDE report 13956786 ↗
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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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