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1 record match for Globus Medical
20191 registryClear
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Not graded by the source2019-09-23FDA MAUDEExcelsiusGPS3004142400-2019-00106ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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.
cause not established3004142400-2019-00106Globus MedicalExcelsiusGPSRead the record ↗