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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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GLOBUS MEDICAL, INC. EXCELSIUS GPS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROBOTIC ARM CONTROL UNIT: GPS-0103
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems Cerebrospinal Fluid Leakage (1772); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/23/2020
Event Type  Injury  
Event Description
The patient had a planned single position lateral decubitus surgery for pedicle screw fixation and interbody fusion from l4-s1. Robotic guidance was planned for placement of pedicle screws from l4-s1 (6 screws) using the globus excelsius gps system. Two surgeons trained to use the globus excelsius gps system, two globus reps and a vascular surgeon were present during the procedure. The ict (intra-operative registration device (reference frame)) is placed in the iliac crest to assist with image merge. A dynamic reference base (drb (motion checker)) is also placed in the iliac crest and acts as surveillance marker for real-time intraoperative accuracy. The robotic software uses an algorithm to register intraoperative fluoroscopy scan images level by level (ap & lateral) and performs a 2d-3d merge with a pre-operative ct scan. This registration is intended to ensure that the radiographic images indicating the intended location of surgery and the actual patient position in the o. R. Matches, thus enabling the robot to guide screw placement. In this case, the software was having difficulty performing the initial image merge and registration. A software reset was advised by the rep. Following the system reset, they were able to complete image merge and registration. Once this was completed, registration scores were generated by the robot, which were reportedly adequate, indicating the images were matched. Palpation of landmarks was completed following registration and compared to the intraoperative images shown on the screen. However, palpation of landmarks as a secondary means of verifying system accuracy in the lateral position is more difficult. Following screw placement, an intra-operative ct scan showed sub-optimal positioning of 6/6 screws. The patient was then flipped onto a prone position for screw revision and replacement with decompression. One screw had penetrated the dura and a csf leak repair was performed. Post-operatively the patient has new foot drop with 0/5 dorsiflexion. The patient has an altered gait and will require rehabilitation services.
 
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Brand NameEXCELSIUS GPS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead ave
valley forge business center
audubon PA 19403
MDR Report Key10828567
MDR Text Key215912539
Report Number10828567
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROBOTIC ARM CONTROL UNIT: GPS-0103
Device Catalogue Number5163-1001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/09/2020
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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