NA 02.211.403Recalls & reported problems
Synthes GmbH · 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM LEFT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982054845), received between May 14, 2018 and May 14, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 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 AN UNKNOWN DATE DUE TO INFECTION. A PLATE, 9 VA LOCKING SCREWS TWO (2) 6.5MM CANNULATED SCREWS, AND TWO (2) 13MM WASHERS WERE REMOVED DURING THE PROCEDURE. IT IS UNKNOWN WHEN AND WHY THE PATIENT WAS ORIGINALLY IMPLANTED WITH THESE DEVICES. ALL THE DEVICES WERE REPORTED AS EASILY REMOVED WITH NO ISSUES. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT IS FOR A 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM LEFT. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: Unspecified Infection
MAUDE report 7510383 ↗
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- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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