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2 records match for Stryker
20161 registryClear
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Not graded by the source2016-11-29FDA MAUDE3005738134-2016-00010Mako Robotic-Arm
Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SIZE 5X9MM ONLAY TIBIAL INSERT WAS INSERTED ON A SIZE 6 TIBIAL BASE PLATE. UPDATE AS PER SALES RESPONSE RECEIVED ON 09-DEC-2016: "REASON FOR REVISION WAS: SURGEON PUT A 5X9 POLY ON A SIZE 6 TIBIA BASE PLATE. IT WAS NOT PRODUCT ERROR. THE 5X9MM WAS REMOVED AND A 6X9MM WAS PUT IN PLACE."
cause not established3005738134-2016-00010StrykerRead the record ↗Not graded by the source2016-07-01FDA MAUDEMW5063331Mako Robotic-Arm
Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOT BY STRYKER ORTHO FAILED. THE SENSORS STOPPED COMMUNICATING WITH THE COMPUTER. THIS HAPPENED AFTER BEGINNING A SURGERY FOR A KNEE REPLACEMENT. THE HOSPITAL HAD TO CALL IN ANOTHER COMPANY TO USE THEIR INSTRUMENTS AND IMPLANTS INSTEAD OF THE MAKO/STRYKER WHICH COULD NOT BE FIXED AFTER 15 MINUTES OF FAILED ATTEMPTS IN THE OPERATING ROOM.
cause not establishedMW5063331StrykerRead the record ↗