NA 02.211.220Recalls & reported problems
Synthes GmbH · 2.4MM/2.7MM VA-LOCKING NAVICULAR PLATE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982054029), received between Jul 9, 2019 and Apr 12, 2024 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- Abscess1
- Bone Fracture(s)1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOOT PLATES IN COLLABORATION WITH DEPUY SYNTHES, TOGETHER WITH CLEVELAND CLINIC FOUNDATION (CCF) 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 #23 23-YEAR-OLD MALE WAS IMPLANTED WITH A VA LCP FOREFOOT/MIDFOOT PLATES (02.211.220) WITH 7 SCREWS. POST OP COMPLICATION WAS REPORTED FOR OSTEOMYELITIS & ABSCESS OF LEFT FOOT. THE COMPLICATION IS NOTED TO BE RELATED TO THE PROCEDURE OR IMPLANTS. TREATMENT: LEFT FOOT I AND D, EXTENSIVE DEBRIDEMENT OF THE LEFT FOOT, REMOVAL OF ALL HARDWARE LEFT FOOT, ULTRASOUND DEBRIDEMENT OF NAVICULAR, PLACEMENT OF ANTIBIOTIC IMPREGNATED OSTEOSET IMPREGNATED VANCOMYCIN BEADS THIS REPORT IS FOR A 2.4MM/2.7MM VA-LOCKING NAVICULAR PLATE. THIS IS REPORT 1 OF 8 FOR (B)(4).
Patient problems: Abscess; Unspecified Infection
MAUDE report 19098637 ↗InjuryJul 9, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF FIVE (5) VARIABLE ANGLE LOCKING SCREWS (REMOVED FROM THE DISTAL END OF PLATE), ONE (1) VARIABLE ANGLE LOCKING NAVICULAR PLATE, AND SIX (6) CORTEX SCREWS DUE TO NONUNION/MALUNION. A VARIABLE ANGLE LOCKING COMPRESSION PLATE CURVED CONDYLAR PLATE WAS REMAINED IMPLANTED BECAUSE IT WAS HOLDING LATERAL LENGTH OF THE FRACTURE. ORIGINALLY, THE PATIENT HAD A DISTAL FEMUR FRACTURE TREATED WITH VA CONDYLAR PLATE AND VA NAVICULAR PLATE ON AN UNKNOWN DATE. THE ANATOMY RESTORED AND FIXED WITH ZIMMER MEDIAL PLATE. THE VARIABLE ANGLE DISTAL FEMUR PLATE REAPPLIED WITH NEW FIVE (5) SCREWS. IT WAS FURTHER REPORTED THAT THE FIVE (5) CORTEX SCREWS REMAINED IN THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 2.4MM/2.7MM VA-LOCKING NAVICULAR PLATE. THIS IS REPORT 2 OF 5 FOR (B)(4).
Patient problems: Bone Fracture(s); No Code Available
MAUDE report 8771222 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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