CoRoent 5281348P2Recalls & reported problems

Nuvasive, Inc. · CoRoent Ant TLIF Ti, 8x11x34mm 8° · Class 2 · Implant

All models of CoRoent (64)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517910387), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

Most reported problems

Device problems

Migration1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 2, 2022Migration; Migration
A POSTERIOR FIXATION CASE WAS PERFORMED USING A NUVASIVE COROENT ANT TLIF TI INTERBODY INSERTED INTO THE L4/5 DISK SPACE IN CONJUNCTION WITH OTHER, UNKNOWN, NON-NUVASIVE DEVICES AND PRODUCTS. DURING POST-OP FOLLOW-UP THE COROENT ANT TLIF TI INTERBODY WAS ALLEGEDLY REPORTED TO HAVE BACKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13654040 ↗

Device details

UDI-DI	`00887517910387`
Brand	CoRoent
Model	5281348P2
Company	Nuvasive, Inc.
Product code	PHM · Intervertebral fusion device with bone graft, thoracic
Class	Class 2
FDA submission	K170962
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Metallic spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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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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