MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS; EXCELSIUS GPS - SPINE SOFTWARE MODEL

Model Number 999.893

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 10/05/2021

Event Type  Death  

Event Description

It was reported that an excelsius robot was in use when a patient experienced adverse health effects and passed away.

Manufacturer Narrative

It was reported that an excelsius robot was in use when a patient experienced adverse health effects and passed away.Additional information provided that no device malfunction or user error occurred during the procedure.Due to the reported effects to the patient not being related to any globus medical products, this event is determined to be not reporteable.The purpose of this report is in an abundance of caution.

• Brand Name: EXCELSIUS GPS
• Type of Device: EXCELSIUS GPS - SPINE SOFTWARE MODEL
• 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: 18856758
• MDR Text Key: 337116315
• Report Number: 3004142400-2021-00244
• Device Sequence Number: 1
• Product Code: OLO
• 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: 02/27/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 999.893
• Device Lot Number: GPS-0295
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White