NA 214.572Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982154286), received between Jan 17, 2019 and Jan 17, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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) 4.5MM CANNULATED SCREW PARTIALLY THREADED. THIS IS REPORT 11 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258836 ↗
• 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) 4.5MM CANNULATED SCREW PARTIALLY THREADED. THIS IS REPORT 4 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258764 ↗
• 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) 4.5MM CANNULATED SCREW PARTIALLY THREADED. THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8258745 ↗