LCP 02.112.519Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982034571), received between Dec 1, 2017 and Dec 1, 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.

• InjuryDec 1, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A MEDIAL DISTAL TIBIA PLATE AND NINE SCREWS ON (B)(6) 2017 DUE TO NONUNION. THE PLATE AND SIX 3.5 CORTICAL AND THREE 3.5 LOCKING SCREWS WERE ORIGINALLY IMPLANTED IN FEBRUARY 2017 DUE TO A WORKMAN¿S COMPENSATION INJURY. THE NONUNION WAS DISCOVERED POST-OPERATIVELY VIA X-RAY ON AN UNKNOWN DATE AND THE SURGEON REQUESTED REVISION SURGERY. BY THE TIME THE REVISION SURGERY COULD BE SCHEDULED THROUGH WORKMAN¿S COMPENSATION, THE PLATE AND TWO CORTICAL SCREWS WERE BROKEN (HEADS OF THE SCREWS WERE BROKEN OFF). THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT WAS REVISED TO A TIBIAL NAIL WITH GOOD OUTCOME. CONCOMITANT DEVICES REPORTED: 3.5 LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY 3), 3.5 CORTICAL SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY 4). THIS REPORT IS FOR ONE (1) 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/LEFT/161MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 7075429 ↗