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U.S. Department of Health and Human Services

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

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GLOBUS MEDICAL, INC. EXCELSIUS GPS; SYSTEM, EXCELSIUS GPS, 120V Back to Search Results
Model Number 6143.1001
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
Investigation confirmed that there was no system malfunction found.The root cause was user technique.The use of a rotated scan for planning resulted in a discrepancy between planned screw location and the patient registration.This resulted in missed screws.Existing mitigations sufficiently reduce risk to health.The issue does not pose a risk to health and there are no new safety concerns associated with this issue.
 
Event Description
It was reported that 4 screws at l2, l3, l5, and s1 were not placed according to plan.The screws were removed and repositioned intra-operatively.
 
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Brand Name
EXCELSIUS GPS
Type of Device
SYSTEM, EXCELSIUS 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 Key10559896
MDR Text Key207718373
Report Number3004142400-2020-00108
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 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number6143.1001
Device Lot NumberGPS-0184
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/24/2020
Initial Date FDA Received09/21/2020
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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