EVOS 72464911NRecalls & reported problems
Smith & Nephew, Inc. · EVOS 3.5MM LATERAL DISTAL FIBULA PLATE 11 HOLE LEFT 147MM · Class 2 · Implant
All models of EVOS (190)
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 00885556645178), received between Aug 6, 2024 and Aug 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2024Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED FRACTURE IN THE EVOS 3.5MM L-D FIBULA PL 11H L 147MM ON (B)(6)2024. IT WAS MENTIONED THAT THE PATIENT HAD NO LOAD BEARING UNTIL AROUND (B)(6) 2024, AND WAS WEARING A PROTECTIVE BOOT. TO ADDRESS THIS ADVERSE EVENT, A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2024. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 19918003 ↗
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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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