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3 records match for Zimmer Biomet
20191 registryClear
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Not graded by the source2019-07-12FDA MAUDE0009617840-2019-00003ROSA Robotic Surgery
ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE SURGEON WAS VALIDATING THE TIBIAL CUTS, THE SYSTEM WAS STATING THAT NOT ENOUGH WAS CUT PER THE PLAN AND THE ROD SHOWED BAD ALIGNMENT. THE SURGEON MADE ADDITIONAL CUTS TO BRING THE TIBIA INTO NEUTRAL ALIGNMENT WHEN HE SWITCHED TO CONVENTIONAL INSTRUMENTATION.
cause not established0009617840-2019-00003Zimmer BiometRead the record ↗Not graded by the source2019-06-21FDA MAUDE0009617840-2019-00004ROSA Robotic Surgery
ROSA Robotic Surgery — 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 AN INITIAL KNEE SURGERY, METAL SHAVINGS WERE NOTICED WHEN DRILLING A TROCHAR PIN THROUGH ONE OF THE HOLES OF THE CUT GUIDE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
cause not established0009617840-2019-00004Zimmer BiometRead the record ↗Not graded by the source2019-06-11FDA MAUDE0009617840-2019-00005ROSA Robotic Surgery
ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION REPORTED.
cause not established0009617840-2019-00005Zimmer BiometRead the record ↗