SECURE-C 714.176SRecalls & reported problems

Globus Medical, Inc. · SECURE-C Endplate & Core Assembly, 11x12, 0&deg, 6mm · Class 3 · Implant

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 00889095179088), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface 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

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

Most reported problems

Device problems

Human-Device Interface Problem1

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.

MalfunctionSep 27, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A SECURE-C IMPLANT NEEDED TO BE REMOVED AFTER BEING DISLODGED INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321907 ↗

Device details

UDI-DI	`00889095179088`
Brand	SECURE-C
Model	714.176S
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.

Other PROSTHESIS, INTERVERTEBRAL DISC devices

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Prodisc C SK PDSXL5
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Simplify® Cervical Artificial Disc
Nuvasive, Inc. · Prosthesis, Intervertebral Disc
1 recall3 reports
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 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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