NA 204.810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982146236), received between Aug 7, 2018 and Jul 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryJul 20, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT REVISED THE PLATE DUE TO SCREWS PULLING OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 10MM. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15070741 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO REVISION ON (B)(6) 2018, TO REMOVE THE FOLLOWING HARDWARE: ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE 6 HOLES, ONE (1) TITANIUM LOCKING SCREW 60MM, ONE (1) TITANIUM LOCKING SCREW 76MM, ONE (1) TITANIUM LOCKING SCREW 30MM, ONE (1) TITANIUM LOCKING SCREW 50MM AND ONE (1) CORTEX SCREW SELF-TAPPING, DUE TO OSTEOMYELITIS. THE HARDWARE WAS ORIGINALLY IMPLANTED FOR A FRACTURE REPAIR SURGERY TO THE RIGHT TIBIA ON AN UNKNOWN DATE IN 2017. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7758297 ↗