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DYONICS 7209075Recalls & reported problems

Smith & Nephew, Inc. · INCISOR PLUS 4.5MM CONCAVE CRV /6 · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010582829), received between May 9, 2018 and May 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Falling” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Falling1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 9, 2018Component Falling

    IT WAS REPORTED THAT THERE WERE SHAVINGS FROM THE BLADE FALLING INTO PATIENT. A BACKUP WAS AVAILABLE, THERE WAS NO DELAY IN THE CASE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7501323 ↗

Other SAW, POWERED, AND ACCESSORIES devices

All SAW, POWERED, AND ACCESSORIES devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.