LCP 238.705Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982162137), received between Oct 2, 2017 and Oct 2, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 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.

• InjuryOct 2, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT SUFFERED A GUNSHOT WOUND ON (B)(6) 2016 AND WAS EX-FIXED THE FOLLOWING DAY. THE PATIENT WAS IMPLANTED WITH AN EIGHT (8)-HOLE PLATE, FOUR (4) LOCKING SCREWS, AND 4 CORTICAL SCREWS ON (B)(6) 2016. ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF PAIN AND PRESENTED A BROKEN PLATE UPON A FOLLOW-UP X-RAY, CAUSING A NONUNION. IT IS UNKNOWN WHY THE PLATE BROKE. THE PATIENT WAS REVISED ON (B)(6) 2017. ALL SCREWS WERE REMOVED INTACT. THE PLATE WAS THE ONLY ONE REPORTED BROKEN. THE PATIENT RECEIVED A NEW PLATE (SAME TYPE - 3.5 MM LCP MEDIAL DISTAL TIBIA PLATE WITHOUT TAB, BUT LONGER IN LENGTH) IN THE TIBIA. THERE WAS A NONUNION AS WELL IN THE FIBULA, WHERE AN ORIGINAL LONG 3.5 MM SCREW DWELLED IN THE INTRAMEDULLARY CANAL. THE FIBULA WAS REVISED WITH A 3.5 MM LOCKING COMPRESSION PLATE (LCP). THE PATIENT WAS ALSO BONE GRAFTED WITH ILIAC BONE (AUTOGRAFT) AND CANCELLOUS CHIPS AT THE FRACTURE SITE OF THE TIBIA TO TRY TO OVERCOME THE NONUNION. THERE WAS NO SURGICAL TIME DELAY NOR PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVED 2 PARTS. CONCOMITANT DEVICES REPORTED: FOUR (4) 3.5 MM LOCKING SCREWS, (4) 3.5 MM CORTEX SCREWS. THIS REPO

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 6909196 ↗