VA-LCP 02.118.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982037602), received between Apr 24, 2018 and Oct 26, 2021 — classified as 4 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION CORRECTION DUE TO NON-UNION AND BROKEN SCREWS. ONE OF FIVE(5) SCREWS 4.0XMM WAS BROKEN WITH SHAFT RETAINED(1) AND THREE OF FOUR(4) SCREWS 2.7XMM VA LOCKING WERE BROKEN WITH SHAFT RETAINED(3). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: EX TIBIA NAIL 8X300 MM (PART# 04.034.240S; LOT# H169638; QUANTITY: 1), UNK - SCREWS: 4.0 MM NAIL LOCKING SCREW (PART# UNK; LOT # UNKNOWN; QUANTITY: 4), PLATE VA MEDIAL DISTAL TIBIA (PART# 02.118.003; LOT# 894268; QUANTITY: 1), UNK - SCREWS: 3.5 MM CORTEX (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 4), UNK - SCREWS: 2.7 MM VA LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES FOUR(4) DEVICES. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP MED DSTL TIBIA PL/4 H/LFT. THIS IS REPORT 2 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12698753 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 07/23/2019: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF THE LEFT ANTEROLATERAL DISTAL TIBIA PLATE WITH SIX (6) HOLES AND LEFT MEDIAL DISTAL TIBIA PLATE WITH FOUR (4) HOLES FROM THE DISTAL TIBIA DUE TO PLATE SITTING PROMINENT AND SOFT TISSUE IRRITATION. ALL HARDWARE WAS REMOVED SUCCESSFULLY, WITH THE EXCEPTION OF TWO (2) BROKEN SCREWS. A TOTAL OF SIX (6) 3.5 MM CORTICAL SCREWS, AND EIGHT (8) 2.7MM VARIABLE ANGLE LOCKING SCREWS WERE REMOVED ALONG WITH THE TWO (2) PLATES. I DO NOT HAVE DATE OF ORIGINAL IMPLANTS. THE BROKEN SCREWS WERE NOT REMOVED BECAUSE THEY WERE BURIED IN BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE REPORTED THIS (B)(4) CAPTURES THE TEN (10) IPS WHILE (B)(4) CAPTURES THE SIX (6) IPS. THIS REPORT IS FOR ONE (1) UNK - SCREWS: LOCKING: TRAUMA. THIS REPORT IS 2 OF 10 FOR (B)(4) .

  Patient problems: Discomfort; No Code Available

  MAUDE report 8808749 ↗
• MalfunctionMay 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN HEX LOW PROFILE SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587126 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN ANKLE PROCEDURE IN (B)(6) 2018 TO IMPLANT TWO (2) LOCKING COMPRESSION PLATE (LCP) ONE THIRD TUBULAR PLATES, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) MEDIAL DISTAL TIBIA PLATE, THIRTEEN (13) 3.5MM CORTEX SCREWS, TWELVE (12) 2.7MM VA LOCKING SCREWS, ONE (1) 7.0MM WASHER, ONE (1) 4.0MM CANNULATED SCREW, AND ONE (1) 4.0MM CANCELLOUS SCREW. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED DUE TO INFECTION, INFLAMMATION, AND DELAYED HEALING. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS OKAY. PATIENT IS REPORTED TO BE INCARCERATED AND NON-COMPLIANT. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA LCP MEDIAL DISTAL TIBIA PLATE. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7944364 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2018 DUE TO PAIN AND DISCOMFORT. IN ADDITION TO THE PAIN AND DISCOMFORT, THE PATIENT REPORTED BEING ABLE TO FEEL THE HARDWARE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) PLATES, TWO (2) 4-HOLE VA MEDIAL DISTAL TIBIA, EIGHT (8) LOCKING SCREWS, SIX (6) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, TWO (2) WASHERS AND A K-WIRE ON AN UNKNOWN DATE. ALL OF THE HARDWARE WERE REMOVED DURING THE (B)(6) PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT INVOLVES 8 DEVICES. THIS REPORT IS 2 OF 8 FOR (B)(4).

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 7454794 ↗