MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED 6.5X50MM POLYAXIAL SCREW

Model Number 5119.1652

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

It was reported that during an extension revision surgery (2) creo threaded 6.5x50mm polyaxial screws were found loose post-operatively.This event occurred in japan.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Neither the device or any imaging could be provided.It is possible that excessive force placed on the spine cause the screws to become loose; however, an exact cause could not be established.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED 6.5X50MM POLYAXIAL SCREW
• 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: 18819074
• MDR Text Key: 336812191
• Report Number: 3004142400-2023-00034
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1652
• Device Lot Number: BAA110XJ/BAW211JH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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 Race: Asian