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3 records match for Stryker
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Not graded by the source2019-07-03FDA MAUDE0002249697-2020-00141Mako 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: PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR MULTIPLE I&D¿S WHILE HOSPITALIZED.
cause not established0002249697-2020-00141StrykerRead the record ↗Not graded by the source2019-05-24FDA MAUDE0002249697-2020-00142Mako 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: PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. ON (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR REVISION OF 1ST REVISION.
cause not established0002249697-2020-00142StrykerRead the record ↗Not graded by the source2019-05-17FDA MAUDE0002249697-2020-00140Mako 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: THIS PI IS FOR REVISION OF PRIMARY. PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT.
cause not established0002249697-2020-00140StrykerRead the record ↗