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

Model Number 6143.1001

Device Problem Human-Device Interface Problem (2949)

Patient Problem Spinal Column Injury (2081)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

It was reported that screws using the excelsius gps system were misplaced intra-operatively and then removed and replaced.

Manufacturer Narrative

Investigation revealed that there was no system malfunction.The purpose of this investigation is to evaluate the risk associated with the identified failure mode of misplaced implants or tools for excelsiusgps.The software shows that l4-l was placed on a steep slope which may cause the implant to skive depending on instrument technique.There was no indication of excessive deflection forces on the end effector; however we do see a large quantity of warnings for ee visibility and camera movements.Skiving can lead to the misplacement of screws.The anticipated overall risk is moderate.The severity observed did not exceed the anticipated severity.The observed overall risk level is moderate, which does match the anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.The cause of the reported issue was traced to user technique.

• Brand Name: EXCELSIUS GPS
• Type of Device: SYSTEM, EXCELSIUS GPS, 120V
• 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: 19203684
• MDR Text Key: 341835379
• Report Number: 3004142400-2024-00076
• 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: 04/22/2024

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-0234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• 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): Other
• Patient Age: 78 YR
• Patient Sex: Female