NA 02.211.405Recalls & reported problems
Synthes GmbH · 2.7MM VA-LOCKING CALCANEAL PLATE LARGE 70MM LEFT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982054883), received between Dec 11, 2020 and Aug 4, 2023 — classified as 2 injuries, 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A VA CALCANEAL PLATE TO TREAT A LEFT SEVERELY COMMINUTED FRACTURE ON AN UNKNOWN DATE. FIFTEEN SCREWS WERE USED FOR FIXATION. THE HARDWARE WAS REMOVED 32 WEEKS POSTOPERATIVELY DUE TO PLATE PROMINENCE AS THE PATIENT WAS ABLE TO FEEL THE HARDWARE WHILE WALKING. THIS REPORT INVOLVES ONE 2.7MM VA-LOCKING CALCANEAL PLATE LARGE 70MM LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17460331 ↗InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2020 THE IMPLANTS WERE REMOVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11224324 ↗MalfunctionDec 11, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE 2.7MM VARIABLE ANGLE (VA) LOCKING SCREW SELF-TAPING WITH T8 STARDRIVE RECESS WOULD NOT LOCK INTO 2.7MM VARIABLE ANGLE LOCKING CALCANEAL PLATE LARGE 70MM LEFT AND HOLE IN PLATE WOULD NOT ACCEPT LOCKING SCREW. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 2.7MM VA-LOCKING CALCANEAL PLATE LARGE 70MM LEFT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10993303 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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