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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 Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 12/15/2021
Event Type  Injury  
Manufacturer Narrative
Investigation revealed there was no system malfunction. Additional information provided that the user applied pressure to the screw heads of s1 during fluoroscopic image acquisition. This can cause a change in the patient anatomy in relation to the dynamic reference base, and lead to navigation integrity issues. The software correctly detected excessive forces and alerted the user. 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 patient experienced adverse effects following surgery where a screw was misplaced intra-operatively.
 
Manufacturer Narrative
Investigation revealed there was no system malfunction. Additional information provided that the user applied pressure to the screw heads of s1 during fluoroscopic image acquisition. This can cause a change in the patient anatomy in relation to the dynamic reference base, and lead to navigation integrity issues. The software correctly detected excessive forces and alerted the user. 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 patient experienced adverse effects following surgery where a screw was misplaced intra-operatively.
 
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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
6109301822
MDR Report Key13306487
MDR Text Key285429068
Report Number3004142400-2022-00011
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D301521
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 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6143.1001
Device Lot NumberGPS-0209
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2021
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 Treatment Data
Date Received: 01/20/2022 Patient Sequence Number: 1
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