SECURE-C 414.307SRecalls & reported problems

Globus Medical, Inc. · SECURE-C Core, 14x16, 7mm · Class 3 · Implant

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 00889095154917), received between May 5, 2026 and May 5, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Disintegration1

Patient problems

Failure of Implant1

Recent adverse event reports

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

MalfunctionMay 5, 2026Material Disintegration
IT WAS REPORTED THAT A REVISION OCCURRED TO REMOVE A SECURE-C IMPLANT FROM A PATIENT THAT WAS EXPERIENCING POLY WEAR OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 25081207 ↗

Device details

UDI-DI	`00889095154917`
Brand	SECURE-C
Model	414.307S
Company	Globus Medical, Inc.
Product code	MJO · PROSTHESIS, INTERVERTEBRAL DISC
Class	Class 3
FDA submission	P100003
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 21, 2021

Device type (GMDN): Cervical total intervertebral disc prosthesis, modular

An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials.

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All PROSTHESIS, INTERVERTEBRAL DISC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.