NA 02.211.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982053848), received between Jan 2, 2024 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 18, 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 THE 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#(B)(6) (60-YEAR-OLD FEMALE) TO CAPTURE. X1 2.4/2.7MM VA-LOCKING X-PLATE SMALL(02.211.202). X4 UNK - SCREWS: LOCKING. PATIENT #(B)(6) 54-YEAR-OLD FEMALE WAS IMPLANTED WITH A VA LCP FOREFOOT/MIDFOOT PLATES (02.211.202) WITH 4 SCREWS. ONE ADDITIONAL ADJUNCTIVE FIXATION SCREWS WAS USED FOR FUSION. POST OP COMPLICATION WAS REPORTED FOR PAINFUL HARDWARE, LEFT FOOT. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. THERE IS NO DEVICE FAILURE NOTED. TREATMENT: REMOVAL OF HARDWARE, LEFT FOOT. THIS REPORT IS FOR ONE (1) 2.4/2.7MM VA-LOCKING X-PLATE SMALL. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19087277 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE WHEN USING A PLATE OUT OF THE 2.7 MIDFOOT FOREFOOT SET THE SURGEON WAS PUTTING IN THE FINAL LOCKING SCREW AND THE SCREW WENT THROUGH THE PLATE. THEY USED THE PROPER DRILL BIT AND THEY ALSO USED A 2.7 VA LOCKING SCREW. LOCKING SCREW WAS REMOVED AND REPLACED WITH A CORTEX SCREW FOR A LARGER HEAD. SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A VA-LOCKING PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424542 ↗