NA 02.211.405SRecalls & reported problems
Synthes GmbH · 2.7MM VA-LOCKING CALCANEAL PLATE LARGE 70MM LEFT-STERILE · 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 10886982054890), received between Sep 19, 2018 and Sep 19, 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
- Erosion1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL SURGERY DUE TO WOUND BREAKDOWN ON (B)(6) 2018. FOUR (4) SELF TAPPING METAPHYSEAL SCREWS, FOUR (4) VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREWS, ONE (1) VA LARGE LOCKING CALCANEAL PLATE, ONE (1) SELF TAPPING CORTEX SCREW WERE REMOVED. ONE (1) SELF TAPPING CORTEX SCREW REMAINED IMPLANTED DUE TO UNKNOWN REASON. ORIGINAL IMPLANT DATE IS ON (B)(6) 2018. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THIS REPORT IS 6 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TEN (10) DEVICES.
Patient problems: Erosion; Not Applicable
MAUDE report 7891837 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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