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7 records match for Globus Medical
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Not graded by the source2021-12-15FDA MAUDEExcelsiusGPS3004142400-2022-00011ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW WAS MISPLACED INTRA-OPERATIVELY.
cause not established3004142400-2022-00011Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2021-10-20FDA MAUDEExcelsiusGPS3004142400-2021-00220ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPOSITION A MISPLACED L5 RIGHT SCREW.
cause not established3004142400-2021-00220Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2021-10-15FDA MAUDEExcelsiusGPS3004142400-2021-00202ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE A MISPLACED LEFT SIDE SCREW FROM THE INITIAL OPERATION. THIS EVENT OCCURRED IN (B)(6).
cause not established3004142400-2021-00202Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2021-08-09FDA MAUDEExcelsiusGPS3004142400-2021-00161ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW WAS MISPLACED AT LS1 AND RIGHT S1, RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED INTRA-OPERATIVELY.
cause not established3004142400-2021-00161Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2021-07-28FDA MAUDEExcelsiusGPS3004142400-2021-00164ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REPRESENTATIVE FROM (B)(6) THAT DRILLING AT L4 TRAJECTORY CAUSED EXCESSIVE BLEEDING TO PATIENT THAT WAS FIXED INTRAOPERATIVELY.
cause not established3004142400-2021-00164Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2021-07-21FDA MAUDEExcelsiusGPS3004142400-2021-00150ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW WAS MISPLACED AT THE LEFT L5 DUE TO PATIENT MOVEMENT RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED INTRA-OPERATIVELY.
cause not established3004142400-2021-00150Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2021-05-10FDA MAUDEExcelsiusGPS3004142400-2021-00103ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE MISPLACED SCREWS AT L4 CAUSING ADVERSE EFFECTS TO THE PATIENT.
cause not established3004142400-2021-00103Globus MedicalExcelsiusGPSRead the record ↗