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

Model Number 6143.1001

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Investigation confirmed that there was no system malfunction found.There was a shift between the ict and drb.The user was presented with a warning statement.Following this, the user was alerted of a potential drb shift.Finally, during navigation the user was alerted to excessive force on the end effector.Excessive force on the end effector can lead to the misplacement of screws.The cause of the reported issue was traced to user technique.

Event Description

It was reported by a representative from (b)(6) that a revision was done to remove and replace the misplaced t6 left and t4 left screws.

• 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: 11995629
• MDR Text Key: 256144994
• Report Number: 3004142400-2021-00114
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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-0201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• 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