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

Model Number 999.893

Device Problem Human-Device Interface Problem (2949)

Patient Problem Spinal Column Injury (2081)

Event Date 09/23/2019

Event Type  malfunction  

Event Description

The system placed screws at ll and l4 accurately, but l2 and l3 were way off.According to the local team, the surveillance was fine and the merge was acceptable.The patient is doing well but had a small dural scratch which was repaired intra-operatively with no serious long-term effect to the patient.

Manufacturer Narrative

This mdr is being submitted for an event that occurred earlier.Engineering investigation revealed that the user accepted shifted registration between patient preoperative ct scan and intra-operative fluoroscopic images.The registration shift was due to the position of the fluoroscope tracker at the time of image capture being inconsistent with its position when the x-ray shot was actually taken.The shift was visible to the user via the marked center (centroid) of each vertebra on each image - images should not be used for which the centroid marks a different point on the anterior-posterior (ap) and lateral shots.The user is required to review and verify the registration before proceeding.Further, the user is encouraged to perform a landmark check to confirm navigation accuracy.There was no malfunction of software.The user accepted fluoroscopic images which were suboptimal for registration.The images were captured such that the position of the fluoroscope tracker was inconsistent with the x-ray shot associated.Due to existing mitigation, there is no unacceptable risk to health.

• Brand Name: EXCELSIUS GPS
• Type of Device: SYSTEM, 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 Key: 18887180
• MDR Text Key: 337465167
• Report Number: 3004142400-2019-00106
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 999.893
• Device Lot Number: GPS-0179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other