MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO ROD

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device could not be returned for evaluation.The post operative imaging from the initial surgery shows rod overhang on one of the iliac screws.It was reported that a medtronic unid contoured rod was used, along with creo amp threaded cocr screws.The creo amp threaded technique guide recommends at least 5mm rod overhang past the screw head in the final construct to ensure that the locking cap is correctly situated on rod.However, there also appears to be an unidentified connection feature at the tip of the rod, situated within the screw head which may prevent proper seating of the locking cap on the rod's curved surface.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a creo rod has loosened post operatively.

• Brand Name: CREO
• Type of Device: CREO ROD
• 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: 18834235
• MDR Text Key: 336872238
• Report Number: 3004142400-2023-00069
• 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: 03/05/2024
• 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: 04/12/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG