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U.S. Department of Health and Human Services

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

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GLOBUS MEDICAL, INC. EXCELSIUS ROBOTICS SYSTEM SYSTEM, EXCELSIUS GPS, 120V Back to Search Results
Model Number 6143.1001
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 02/20/2022
Event Type  Injury  
Manufacturer Narrative
Investigation revealed that there was no system malfunction. The entire vertebral body of l3 is not captured within the preoperative ct scan. The inferior end plate is omitted from the scan. This can contribute to difficulties in obtaining a successful merge. Users are trained on the appropriate imaging acquisition protocol during the excelsiusgps training pathway. Additionally, for levels where screws were misplaced, the fluoroscopic ap images contained tracking errors. A tracking error can be caused if the position of the c-arm changed between when the original x-ray was emitted and when the image is uploaded to the system. Furthermore, there is a shift present in the ap image of the preoperative merge. Tracking errors and merge shifts can cause navigation integrity issues and can lead to the misplacement of screws. The user must verify the merge before proceeding to navigation. After verifying the merge, the software prompts the user to perform an anatomical landmark check before proceeding with navigation. The cause of the reported issue was traced to user technique.
 
Event Description
It was reported that a revision surgery was done to remove and replace misplaced screws.
 
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Brand NameEXCELSIUS ROBOTICS SYSTEM
Type of DeviceSYSTEM, 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 Key13862148
MDR Text Key287696327
Report Number3004142400-2022-00041
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6143.1001
Device Lot NumberGPS-0121
Was Device Available for Evaluation? No
Date Manufacturer Received02/21/2022
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 Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1
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