SECURE-C 714.200SRecalls & reported problems

Globus Medical, Inc. · SECURE-C Endplate Assembly, 13x14, 0&deg · Class 3 · Implant

Data updated Oct 13, 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 00889095179095), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Insufficient Device Problem Information1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionMar 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A SECURE-C ENDPLATE ASSEMBLY AND CORE FOR UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 18825186 ↗

Device details

UDI-DI	`00889095179095`
Brand	SECURE-C
Model	714.200S
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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Simplify® Cervical Artificial Disc
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Simplify® Cervical Artificial Disc
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All PROSTHESIS, INTERVERTEBRAL DISC devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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