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U.S. Department of Health and Human Services

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

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GLOBUS MEDICAL, INC. EXCELSIUS GPS EXCELSIUS GPS, 120V Back to Search Results
Model Number 6143.1001
Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
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. The user then reset the surveillance marker without updating the registration and proceeded to navigation. Additionally, during both l5 trajectories, the software detected excessive forces on the load cell during bone work. This is the result of skiving forces detected while a tool is inserted in the end effector. 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 revision surgery was done to remove a misplaced left side screw from the initial operation. This event occurred in (b)(6).
 
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Brand NameEXCELSIUS GPS
Type of DeviceEXCELSIUS 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 Key12642889
MDR Text Key276826086
Report Number3004142400-2021-00202
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6143.1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
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 Treatment Data
Date Received: 10/15/2021 Patient Sequence Number: 1
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