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2 records match for Globus Medical
2 death reports2021–20251 registryClear
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Death reported2025-10-15FDA MAUDEExcelsiusGPS3004142400-2025-00280ExcelsiusGPS
ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE HOSPITAL THEIR ELDERLY PATIENT WITH A THORACIC FRACTURE. THE PATIENT WAS UNWELL AND EVEN HAD AN ISSUE DURING THE SURGERY. EGPS WAS USED WITH E3D AND ALL SCREWS WERE EXECUTED. UNFORTUNATELY THE NEXT DAY THE PATIENT PASSED AWAY. POST OP IMAGING CONFIRMS SCREWS WERE ACCURATE BUT THERE WERE QUESTIONS ABOUT THE ROBOTIC CASE. NO SCREWS WERE FOUND DEVIATED TO HAVE A CLINICAL DEFICIT.
cause not established3004142400-2025-00280Globus MedicalExcelsiusGPSRead the record ↗Death reported2021-10-05FDA MAUDEExcelsiusGPS3004142400-2021-00244ExcelsiusGPS
ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AN EXCELSIUS ROBOT WAS IN USE WHEN A PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS AND PASSED AWAY.
cause not established3004142400-2021-00244Globus MedicalExcelsiusGPSRead the record ↗