LCP 02.112.526Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982034632), received between Aug 17, 2017 and Aug 17, 2017 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5MM LOCKING COMPRESSION PLATE (LCP) LOW BEND MEDICAL DISTAL TIBIA PLATE AND NINE (9) UNKNOWN CORTEX SCREWS WERE REMOVED ON (B)(6) 2017 DUE TO THREE (3) BROKEN SCREWS. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON (B)(6) 2017 DUE TO A MID-SHAFT TIBIA FRACTURE. THE PATIENT FELL ON AN UNKNOWN DATE POSTOPERATIVELY. IT WAS DETERMINED BY X-RAY THAT THREE (3) SCREWS WERE BROKEN. ALL HARDWARE WAS REMOVED AND PATIENT WAS NOT REVISED TO ADDITIONAL HARDWARE. THERE WAS A 10 MINUTE SURGICAL DELAY TO DRILL AROUND THE SCREWS TO TRY TO REMOVE THEM. A PORTION OF ONE (1) SCREW COULD NOT BE REMOVED AND REMAINS IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH GOOD PATIENT OUTCOME. POSSIBLE INFECTION WAS NOTED AND THE DEVICES WERE SENT TO PATHOLOGY. THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 6800457 ↗