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

Model Number 6143.1001

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2022

Event Type  Injury  

Event Description

It was reported that a revision surgery was needed to remove and replace misplaced screws that were placed using the excelsius gps system.

Manufacturer Narrative

Investigation revealed there was no system malfunction.Investigation of the case logs and a comparison of the intra-operative scan to post-operative spin revealed that there was movement of the intra-operative ct registration fixture (ict).This movement occurred between when the surgical snapshot is captured and when the scan is uploaded to the system.A shift of the ict can lead to a loss of navigation integrity and the misplacement of screws.The user acknowledges that they will perform an anatomical landmark check on the operative levels to ensure navigation integrity after the registration and before navigation.The cause of the reported issue was traced to user technique.

• Brand Name: EXCELSIUS
• 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: 15182134
• MDR Text Key: 297412115
• Report Number: 3004142400-2022-00114
• 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: 08/02/2022

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 Model Number: 6143.1001
• Device Lot Number: GPS-0184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/08/2022
• 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: 66 YR
• Patient Sex: Female