MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS; SYSTEM, EXCELSIUS GPS, 120V

Model Number 6143.1001

Device Problem Malposition of Device (2616)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

Investigation confirmed that there was no system malfunction found.A surveillance marker was registered, but only after the patient was registered.This could lead to movement of the patient reference array during imaging of the patient going unnoticed and results in tracking errors.There was a shift between the intra-operative fluoroscopic images and the pre-operative ct scan.This shift results in poor-quality patient registration.The user was alerted of high skiving force while working on all levels.Heavy skiving could lead to movement of the anatomy.These factors all contributed to the misplacement of the screws.The cause of the reported issue was due to user technique.

Event Description

It was reported by a representative from (b)(6) that 2 screws were misplaced.Upon removal of the second screw, the internal iliac artery was perforated causing blood loss to the patient.This was resolved and the patient is recovering.

• Brand Name: EXCELSIUS GPS
• Type of Device: SYSTEM, EXCELSIUS GPS, 120V
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11165593
• MDR Text Key: 227099598
• Report Number: 3004142400-2020-00009
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171651
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6143.1001
• Device Lot Number: GPS-0237
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/13/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 60