EVOS 72469510Recalls & reported problems
Smith & Nephew, Inc. · EVOS 3.5MM SUPERIOR MIDSHAFT CLAVICLE PLATE 10 HOLE LEFT 108MM · 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 00885556726808), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning Failure” (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.
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT, DURING FIXATION PROCEDURE, THE TABS OF THE EVOS 3.5MM SUP MS CLAV PL 10H L 108MM DID NOT HOLD THE SCREW. THE PLATE WAS IMPLANTED AND HAD TO BE REMOVED, ALSO THE SCREWS WERE REMOVED. SURGEON DID A TWO PLATE CONSTRUCT WITH ONE OF THEIR ANTERIOR PLATES, PLUS A COMPETITORS LATERAL PLATE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16491553 ↗
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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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