MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO LOCKING CAP

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.The imaging provided confirms that the right locking cap at l5 had migrated.According to the images, there was no visible cement in the screw head which may have prevented the locking cap from properly locking.It was reported that the patient fell two weeks post operatively which may result in excessive in vivo forces on the construct.However, no determinations of could be made as to the cause of the reported issue.

Event Description

It was reported that there was a revision surgery due to creo locking caps that migrated after a patient fell two weeks post operatively.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO LOCKING CAP
• 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: 18821034
• MDR Text Key: 336872684
• Report Number: 3004142400-2023-00040
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other