• 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 03/07/2022
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. The preoperative merges of t4 and t9 both contain shifts. Merge shifts can cause navigation integrity issues and lead to the misplacement of screws. The user must verify the merge before proceeding to navigate. 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.
 
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
6109301800
MDR Report Key14253483
MDR Text Key290454302
Report Number3004142400-2022-00064
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 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6143.1001
Device Lot NumberGPS-0242
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2022
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: 04/29/2022 Patient Sequence Number: 1
-
-