Cohere 1814365Recalls & reported problems
Nuvasive, Inc. · COHERE TLIF-A Inserter, Offset · Class 2
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 00887517017581), received between Oct 10, 2023 and Oct 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- Device Damaged by Another Device1
- Mechanical Problem1
- Positioning Problem1
- Unintended Movement1
Patient problems
- Unspecified Nervous System Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2023Mechanical Problem; Device Damaged by Another Device; Positioning Problem; Unintended Movement; Activation Problem; Mechanical Problem; Device Damaged by Another Device; Positioning Problem; Unintended Movement; Activation Problem
REP REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE THE RESIDENT PLACED THE CAGE WITHOUT ISSUE BUT WAS UNCOMFORTABLE WITH THE POSITION, SO THE INSERTER WAS REATTACHED, AND SLAP HAMMERED BACK OUT. DURING THE STATED REMOVAL THE INSERTERS (1814364 LOT TI1718 STRAIGHT) DOWEL PIN CAME LOOSE, AND IT WAS NO LONGER USABLE. THE CAGE WAS THEN ATTACHED TO THE OFF-SET INSERTER (1814365 LOT TI1580) FOR PLACEMENT. DURING THIS SECOND IMPACTION OF THE SAME CAGE IN-CASE NEURAL MONITORING OF THE PATIENT (THIRD PARTY CADWELL) IDENTIFIED MOTOR DEFICIT HAD TAKEN PLACE AND THE APPROACH WAS ABORTED, THE RESIDENT CLAIMS THAT THE INSERTER WAS ALLOWING THE IMPLANT TO PIVOT PREMATURELY IT BECAME LOOSE AND DID NOT ENGAGE THE INTERBODY FULLY DURING IMPLANTATION. THE PEEK INTERBODY WAS DISCARDED AT THE USER FACILITY AND UNAVAILABLE FOR EVALUATION.
Patient problems: Unspecified Nervous System Problem
MAUDE report 17906238 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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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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