MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X40MM POLYAXIAL SCREW

Model Number 5119.1642

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.It was reported that two creo threaded 6.5x40mm polyaxial screws fractured in the s1 pedicles.Images returned show that the reported fracture occurred in both s1 screws about 1/3 of the screw length from the proximal side.The initial surgery was a posterior lateral fusion from l4-s1 and is reported to have occurred on (b)(6) 2022.The patient had an l5-s1 alif performed on (b)(6) 2023 with hedron ia because she refused posterior surgery.A follow up evaluation showed that one of the hedron ia locking screws backed out.This prompted the surgeon to replace the fractured s1 screws.These fractures are indicative of high forces or repetitive stresses being placed on the screws and a lack of fusion over time, however, it is unknown exactly how this failure may have occurred.Only images were returned, so the full scope of the patient's applicable anatomy and the wear shown on each screw is unknown.The surgical and post-operative conditions cannot be replicated.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a revision was needed due to creo threaded screws that were found broken post operatively. .

• Brand Name: CREO
• Type of Device: CREO THREADED 6.5X40MM 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: 18810545
• MDR Text Key: 336811251
• Report Number: 3004142400-2023-00197
• 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

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1642
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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