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4 records match for Stryker
20211 registryClear
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Not graded by the source2021-12-15FDA MAUDE0002249697-2022-00054Mako 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: DR. PERFORMED AN I&D AND REVISED A MAKO TIBIAL INSERT THAT WAS ORIGINALLY DONE BY DR. ON (B)(6) 2021 DUE TO INFECTION. RIGHT KNEE.
cause not established0002249697-2022-00054StrykerRead the record ↗Not graded by the source2021-07-06FDA MAUDE0002249697-2021-01295Mako 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: DR...PERFORMED AN I&D WITH TIBIAL INSERT EXCHANGE DUE TO POSSIBLE INFECTION OF A LEFT MEDIAL UNI.
cause not established0002249697-2021-01295StrykerRead the record ↗Not graded by the source2021-04-23FDA MAUDE0002249697-2021-00872Mako 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: DURING A MAKO PKA CASE AN INCORRECT SIZE 3 POLY INSERT WAS IMPLANTED ONTO A SIZE 4 TIBIAL BASEPLATE. THE ERROR WAS DISCOVERED BY THE SURGEONS REG AFTER THE PATIENT HAD JUST BEEN CLOSED. THE PATIENT WAS REOPENED AND THE CORRECT SIZE 4 POLY INSERTED. PROBLEM RESOLVED. NO NEW SPINAL OR GA WAS NEEDED.
cause not established0002249697-2021-00872StrykerRead the record ↗Not graded by the source2021-02-24FDA MAUDE0002249697-2021-00505Mako 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: IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT MAKO PKA DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE PRIMARY IMLANT SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
cause not established0002249697-2021-00505StrykerRead the record ↗