LCP 02.112.141Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982033956), received between Oct 23, 2017 and Feb 22, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLATING A DISTAL FIBULA, THE SURGEON WAS UNABLE TO GET THE PLATE TO FIT THE PATIENT¿S ANATOMY PROPERLY. THE SURGEON EXPLAINED THAT THE PLATE COULD NOT CONFORM TO THE FIBULA AND THE PLATE WAS MAL-REDUCING THE FRACTURE. THE PLATE WAS REMOVED AND EXCHANGED FOR A 1/3 TUBULAR PLATE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/LEFT/99MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579776 ↗
• InjuryJul 7, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO A PROMINENT PLATE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 6) UNKNOWN CORTEX SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 3) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.7/3.5 LCP LAT DSTL FIB PL 5H/LFT/99 THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12128249 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND BREAKDOWN AROUND THE LATERAL SIDE OF THE ANKLE. A LATERAL DISTAL FIBULA PLATE, FIVE 3.5MM CORTEX SCREWS, ONE 2.7MM CORTEX SCREW, AND FIVE 2.7MM LOCKING SCREWS WERE ORIGINALLY IMPLANTED IN ORDER TO TREAT A BIMALLALEOR ANKLE FRACTURE TWO MONTHS AGO. THE BONE APPEARED TO HAVE HEALED NICELY AND THE WOUND DID NOT BREAK DOWN TO THE HARDWARE. AS A PRECAUTION, THE LATERAL PLATES AND SCREWS WERE TAKEN OUT. NO INFECTION WAS IDENTIFIED AND NO ALLEGATIONS WERE MADE AGAINST THE IMPLANTED DEVICES. ALL DEVICES WERE REMOVED EASILY AND NO FRAGMENTS WERE GENERATED. CONCOMITANT DEVICES REPORTED: UNKNOWN 3.5MM CORTEX SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 5), UNKNOWN 2.7MM CORTEX SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QTY 1), UNKNOWN 2.7MM LOCKING SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 5). THIS REPORT IS FOR ONE (1) 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/LEFT/99MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 6968643 ↗