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

Model Number 6143.1001

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Investigation revealed no system malfunction was found.The software correctly detected the dynamic reference base shift and displayed the on-screen warning message and alerted the user of a surveillance shift.Navigation proceeded without complete resolution of the error message.Evaluation of the case and case logs found that the cause of the reported issue was traced to user error.To successfully move forward with the case following the warning, the user would need to have performed anatomical landmark checks or collect new imaging for the patient.

Event Description

It was reported that a representative from (b)(6) that drilling at l4 trajectory caused excessive bleeding to patient that was fixed intraoperatively.

• 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: 12328339
• MDR Text Key: 266841434
• Report Number: 3004142400-2021-00164
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6143.1001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other