NA 204.870Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982146564), received between Jan 17, 2019 and Jan 12, 2022 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A DERMATOLOGIST TAKING CARE OF A PATIENT WITH SEVERE RASH POSSIBLY RELATED TO METAL ALLERGY. HE HAS A COBALT ALLERGY AND QUESTIONABLE GOLD ALLERGY. HE HAD SURGERY IN 2018 AND HAD TWO OF YOUR SCREWS, PER THE OP RECORD OF A ONE (1) 3.5MM CORTEX SCREW, SELF-TAPPING AND ONE (1) 3.5MM STAINLESS STELL CORTEX SCREW, SELF-TAPPING WITH HEX RECESS. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 60MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13237115 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 6 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258651 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 5 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258612 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE LOW BEND HOLES, THREE (3) CORTEX SCREW SELF-TAPPING, FOUR (4) VARIABLE ANGLE LOCKING SCREW, STARDRIVE RECESS, SELF-TAPPING AND THREE (3) CANNULATED SCREW PARTIALLY THREADED DUE TO INFECTION. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW. THIS IS REPORT 2 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258574 ↗