NA 400.734ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587044903), received between Mar 24, 2023 and Mar 24, 2023 — classified as 2 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 2 most recent of 2 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 4MM. THIS IS REPORT 10 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612155 ↗
• 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 4MM. THIS IS REPORT 1 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16611509 ↗