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139 records match for Globus Medical
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Not graded by the source2024-12-12FDA MAUDEExcelsiusGPS3004142400-2025-00106ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2025-00106Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-12-10FDA MAUDEExcelsiusGPS3004142400-2025-00007ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN SPAIN.
cause not established3004142400-2025-00007Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-12-03FDA MAUDEExcelsiusGPS3004142400-2024-00309ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00309Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-12-01FDA MAUDEExcelsiusGPS3004142400-2024-00546ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PLUGGED THE EGPS INTO THE MAINS POWER SUPPLY AND NOT RECEIVING ANY POWER, TRIED MULTIPLE SOCKETS BUT NO POWER.
cause not established3004142400-2024-00546Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-11-29FDA MAUDEExcelsiusGPS3004142400-2024-00305ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.
cause not established3004142400-2024-00305Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-11-26FDA MAUDEExcelsiusGPS3004142400-2024-00304ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00304Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-11-14FDA MAUDEExcelsiusGPS3004142400-2024-00296ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00296Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-11-08FDA MAUDEExcelsiusGPS3004142400-2024-00291ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.
cause not established3004142400-2024-00291Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-11-07FDA MAUDEExcelsiusGPS3004142400-2024-00289ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, A ROBOTIC ERROR TOOK OVER 40 MINUTES TO RESOLVE WITH THE PATIENT UNDER ADDITIONAL ANESTHESIA.
cause not established3004142400-2024-00289Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-11-05FDA MAUDEExcelsiusGPS3004142400-2024-00293ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00293Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-31FDA MAUDEExcelsiusGPS3004142400-2024-00299ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L4 SCREW.
cause not established3004142400-2024-00299Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-31FDA MAUDEExcelsiusGPS3004142400-2024-00241ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOT NOT POWERING ON.
cause not established3004142400-2024-00241Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-30FDA MAUDEExcelsiusGPS3004142400-2024-00287ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.
cause not established3004142400-2024-00287Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-30FDA MAUDEExcelsiusGPS3004142400-2024-00292ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00292Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-24FDA MAUDEExcelsiusGPS3004142400-2024-00280ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.
cause not established3004142400-2024-00280Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-24FDA MAUDEExcelsiusGPS3004142400-2024-00283ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00283Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-24FDA MAUDEExcelsiusGPS3004142400-2024-00284ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00284Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-15FDA MAUDEExcelsiusGPS3004142400-2024-00266ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00266Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-14FDA MAUDEExcelsiusGPS3004142400-2024-00263ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00263Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-14FDA MAUDEExcelsiusGPS3004142400-2024-00273ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO THE ROBOT BECOMING UNRESPONSIVE, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.
cause not established3004142400-2024-00273Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-11FDA MAUDEExcelsiusGPS3004142400-2024-00275ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00275Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-11FDA MAUDEExcelsiusGPS3004142400-2024-00272ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00272Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-09FDA MAUDEExcelsiusGPS3004142400-2024-00254ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO MERGE ISSUE.
cause not established3004142400-2024-00254Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-07FDA MAUDEExcelsiusGPS3004142400-2024-00252ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00252Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-01FDA MAUDEExcelsiusGPS3004142400-2025-00002ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2025-00002Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-10-01FDA MAUDEExcelsiusGPS3004142400-2024-00244ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00244Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-30FDA MAUDEExcelsiusGPS3004142400-2024-00242ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.
cause not established3004142400-2024-00242Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-30FDA MAUDEExcelsiusGPS3004142400-2024-00243ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.
cause not established3004142400-2024-00243Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-27FDA MAUDEExcelsiusGPS3004142400-2024-00269ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED WITHOUT ROBOT.
cause not established3004142400-2024-00269Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-26FDA MAUDEExcelsiusGPS3004142400-2024-00290ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED SHORTLY AFTER THE PATIENT DISPLAYED SUSPECTED PRESENCE OF STROKE AND/OR HEMATOMA.
cause not established3004142400-2024-00290Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-26FDA MAUDEExcelsiusGPS3004142400-2024-00271ExcelsiusGPS
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 SCREWS USING THE EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00271Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-25FDA MAUDEExcelsiusGPS3004142400-2024-00255ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO MERGE ISSUE.
cause not established3004142400-2024-00255Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-25FDA MAUDEExcelsiusGPS3004142400-2024-00247ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00247Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-23FDA MAUDEExcelsiusGPS3004142400-2024-00233ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00233Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-19FDA MAUDEExcelsiusGPS3004142400-2024-00260ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00260Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-19FDA MAUDEExcelsiusGPS3004142400-2024-00234ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00234Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-18FDA MAUDEExcelsiusGPS3004142400-2024-00294ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00294Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-18FDA MAUDEExcelsiusGPS3004142400-2024-00230ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.
cause not established3004142400-2024-00230Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-18FDA MAUDEExcelsiusGPS3004142400-2024-00229ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.
cause not established3004142400-2024-00229Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-17FDA MAUDEExcelsiusGPS3004142400-2024-00235ExcelsiusGPS
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 NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.
cause not established3004142400-2024-00235Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-11FDA MAUDEExcelsiusGPS3004142400-2024-00225ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L1R SCREW.
cause not established3004142400-2024-00225Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-05FDA MAUDEExcelsiusGPS3004142400-2024-00217ExcelsiusGPS
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 DURING A PROCEDURE USING THE EXCELSIUS CRANIAL APPLICATION, A BIOPSY SAMPLE WAS TAKEN AND CAUSED EXCESSIVE BLEEDING.
cause not established3004142400-2024-00217Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-09-03FDA MAUDEExcelsiusGPS3004142400-2024-00208ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND USING FLURO.
cause not established3004142400-2024-00208Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-30FDA MAUDEExcelsiusGPS3004142400-2024-00213ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ISSUES WITH MERGING.
cause not established3004142400-2024-00213Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-28FDA MAUDEExcelsiusGPS3004142400-2024-00212ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.
cause not established3004142400-2024-00212Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-27FDA MAUDEExcelsiusGPS3004142400-2024-00207ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00207Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-23FDA MAUDEExcelsiusGPS3004142400-2024-00220ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND USING FLURO.
cause not established3004142400-2024-00220Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-20FDA MAUDEExcelsiusGPS3004142400-2024-00209ExcelsiusGPS
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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.
cause not established3004142400-2024-00209Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-15FDA MAUDEExcelsiusGPS3004142400-2024-00200ExcelsiusGPS
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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY FLURO DURING SURGERY.
cause not established3004142400-2024-00200Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2024-08-14FDA MAUDEExcelsiusGPS3004142400-2024-00579ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WOULD NOT TURN ON AT (B)(6). WE ASSUME A FUSE HAS BLOWN.
cause not established3004142400-2024-00579Globus MedicalExcelsiusGPSRead the record ↗