• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GLOBUS MEDICAL, INC. EXCELSIUS SYSTEM, EXCELSIUS GPS, 120V Back to Search Results
Model Number 6143.1001
Device Problem Malposition of Device (2616)
Patient Problem Insufficient Information (4580)
Event Date 10/20/2021
Event Type  Injury  
Manufacturer Narrative
Investigation revealed there was no system malfunction. For the level of l5-r, 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. Software correctly detected the warning and alerted the user. The user proceeded with navigation and placement of the screw. The cause of the reported issue was traced to user technique.
 
Event Description
It was reported that a revision surgery was done to reposition a misplaced l5 right screw.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXCELSIUS
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 Key12846884
MDR Text Key281073234
Report Number3004142400-2021-00220
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 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6143.1001
Device Lot NumberGPS-0136
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2021
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: 11/19/2021 Patient Sequence Number: 1
-
-