NA 400.738ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587044989), received between Mar 24, 2023 and Mar 24, 2023 — classified as 6 malfunctions.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON (B)(6) 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 8MM. THIS IS REPORT 12 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612274 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON MARCH, 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 8MM. THIS IS REPORT 11 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612272 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON (B)(6) 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 8MM. THIS IS REPORT 13 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612270 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON (B)(6) 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 8MM. THIS IS REPORT 8 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612117 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MARCH 7, 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON (B)(6) 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 8MM. THIS IS REPORT 9 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612112 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MARCH 7, 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON (B)(6) 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 8MM.

  Patient problems: Unspecified Infection

  MAUDE report 16611508 ↗