NA 02.211.204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982053886), received between Nov 6, 2018 and Apr 11, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT, IN COLLABORATION WITH DEPUY SYNTHES, DR., TOGETHER WITH CLINIC FOUNDATION DATABASE DESIGNERS, PROGRAM MANAGERS, RESEARCH ASSISTANTS, AND BIOSTATISTICIANS, HAS DEVELOPED A REPORT THAT SUMMARIZES SAFETY AND EFFECTIVENESS DATA ON 100 PATIENTS WHO UNDERWENT FOOT SURGERY AT CCF BETWEEN 2008 AND 2023 UTILIZING DEPUY SYNTHES (DPS) FOOT PLATES. SOME PATIENTS WERE NOTED TO HAVE ADJUNCTIVE DEPUY SYNTHES DEVICES USED OUTSIDE OF THE PLATES/SCREWS. PATIENT #9 63-YEAR-OLD MALE WAS IMPLANTED WITH A VA LCP FOREFOOT/MIDFOOT PLATES (02.211.204) WITH 4 SCREWS. ONE ADDITIONAL ADJUNCTIVE FIXATION SCREW + BIOMATERIALS WAS USED FOR FIXATION/FUSION & BONE LOSS. POST OP COMPLICATION WAS REPORTED FOR INFECTION OF LEFT FOOT. THE COMPLICATION IS NOTED TO BE NOT RELATED TO THE PROCEDURE OR IMPLANTS. TREATMENT: INCISION AND DRAINAGE OF INFECTION LEFT FOOT, REMOVAL OF ALL HARDWARE THROUGH 2 INCISIONS, PULSATILE IRRIGATION, APPLICATION OF WOUND VAC TO 2 WOUNDS. SURGEON MONITORED FLUOROSCOPY TO CONFIRM ALL HARDWARE REMOVAL AND STABILITY OF ARTHRODESES. THIS REPORT IS FOR ONE (1) 2.4/2.7MM VA-LOCKING X-PLATE LARGE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19088022 ↗
• MalfunctionNov 6, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A CALCANEOCUBOID FUSION ON (B)(6) 2018, TWO (2) SCREWS DID NOT LOCK INTO THE X-PLATE FROM A 4-FOOT MIDFOOT SYSTEM. UPON REMOVAL OF THE PLATE, THERE WAS A TYPE OF DEFORMITY WITHIN THE SCREW HOLE IN THE PLATE THAT WOULD NOT ALLOW THE THREADS IN THE LOCKING SCREW TO ENGAGE. NO FRAGMENTS WERE FOUND. THERE WAS A SURGICAL DELAY OF 30-40 MINUTES. PROCEDURE OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 2) . THIS REPORT IS FOR ONE (1) 2.4/2.7MM VA-LOCKING X-PLATE LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8043504 ↗