NA 400.736ERecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10887587044941), received between Mar 23, 2023 and Mar 31, 2023 — classified as 21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16654598 ↗
• MalfunctionMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS REPORT IS FOR A VETERINARY CASE. THERE WAS NO HUMAN PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6 THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16654597 ↗
• MalfunctionMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 3/07/2023 VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6 THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16622458 ↗
• MalfunctionMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ON (B)(6) 2023, VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6)19. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16622448 ↗
• MalfunctionMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STING FLUTES 6 THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16622420 ↗
• 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6 THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 14 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614999 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 3/07/2023, THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6). SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAS INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 13 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614937 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 3/07/2023, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 12 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614919 ↗
• 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6 THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4) & (B)(4). THIS IS REPORT 11 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614806 ↗
• 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4) & (B)(4). THIS IS REPORT 10 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614754 ↗
• 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 9 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614722 ↗
• 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 6 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614617 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 3/07/2023, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6)2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 8 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614582 ↗
• MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 3/07/2023, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6 THIS COMPLAINT IS RELATED TO THESE COMPLAINTS: (B)(4). THIS IS REPORT 7 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16614527 ↗
• 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 6MM CLOSE. THIS IS REPORT 14 OF 14 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 16612277 ↗
• 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 6MM. THIS IS REPORT 2 OF 14 FOR COMPLAINT

  Patient problems: Unspecified Infection

  MAUDE report 16611537 ↗
• MalfunctionMar 23, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 5 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16605321 ↗
• MalfunctionMar 23, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 4 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16603983 ↗
• MalfunctionMar 23, 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 12/17/19. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 3 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16603934 ↗
• MalfunctionMar 23, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH ((B)(6) 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 1 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16603932 ↗
• MalfunctionMar 23, 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. SHE WILL BE REMOVING THE HARDWARE LATER THIS MONTH (MARCH 2023). HE HAVE INCLUDED ALL OF THE IMPLANTS USED IN THE ORIGINAL SURGERY. THEY ARE UNSURE WHICH ONES CAUSED THE INFECTION. THEY WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED. THIS COMPLAINT INVOLVES FOURTEEN(14) DEVICES. THIS REPORT IS FOR ONE (1) 1.5 TI MF CORTEX SCREW STPING FLUTES 6. THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16603930 ↗