LCP 240.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982164537), received between Aug 28, 2017 and Feb 9, 2018 — classified as 2 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 16, 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.

• InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A NON UNION OF A PROXIMAL THIRD TIBIA FRACTURE. THE ORIGINAL IMPLANT DATE WAS ABOUT 10 YEARS AGO. THE PLATE HAD THREE (3) 5.0MM LOCKING SCREWS AND THREE (3) CANNULATED 5.0MM LOCKING SCREWS. IMPLANTS WERE REMOVED WITHOUT ANY MAJOR ISSUE. THE PATIENT WAS PLACED WITH ANOTHER SYNTHES PLATE AND VIVIGEN BONE GRAFT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION NEEDED. NO SURGICAL DELAY WAS NOTED NO FRAGMENTS WERE REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) PLATE. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7259090 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A TIBIA PLATE, FOUR CANNULATED LOCKING SCREWS, AND THREE CORTEX SCREWS DUE TO INFECTION, INFLAMMATION, AND NONUNION ON (B)(6) 2017. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROXIMAL LEFT TIBIAL PLATEAU FRACTURE. THE PATIENT FAILED TO FOLLOW POSTOPERATIVE DIRECTIONS WHICH INCLUDED REMOVING BANDAGE TOO EARLY POSTOPERATIVELY AND WALKING ON LEG BEFORE HE WAS DIRECTED TO. THE SURGEON STATED THAT THE INFECTION WAS DUE TO THE PATIENT'S NONCOMPLIANCE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS OKAY. THIS COMPLAINT IS (3) DEVICES 1 PLATE, UNK CORTEX SCREWS, UNK LOCKING SCREWS. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 6825934 ↗