MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE-C; SECURE-C ENDPLATE ASSEMBLY, 13X14, 0 DEGREE

Model Number 714.200S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.A revision surgery was performed approximately one year after implantation to remove a secure-c endplate assembly and core from the c6-7 level.The secure-c implant is comprised of two components, secure-c endplate assembly (714.200s) and secure-c core (414.207s}.The fluoroscopic image, taken during the revision surgery, showed parallel spacing between the implant endplates indicating the potential presen ce of the core within the confines of the implant.Examination showed no evidence of structural defects other than minor scratches and gouge marks that are consistent with the use of surgical instruments during removal.The exact reason for the revision was not provided; however, it was stated that the implant was not broken prior to removal.No determinations could be made as to the reason for the removal.

Event Description

It was reported that a revision surgery was performed to remove a secure-c endplate assembly and core for unknown reasons.

• Brand Name: SECURE-C
• Type of Device: SECURE-C ENDPLATE ASSEMBLY, 13X14, 0 DEGREE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18825186
• MDR Text Key: 336795629
• Report Number: 3004142400-2018-00020
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00889095179095
• UDI-Public: 00889095179095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 714.200S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Race: White