Edge One Platinum EOPPRI31Recalls & reported problems
US Endodontics, LLC · Endodontic Reciprocating Files · 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 00819514020721), received between Nov 18, 2024 and Nov 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2024Break; Break
FILE BROKE INSIDE THE TOOTH AND WAS NOT ABLE TO BE REMOVED. THE PATIENT WAS REFERRED TO AN ENDODONTIST FOR A CONSULT. AS OF THIS DATE OF THIS REPORT, NO ENDODODONTIC APPOINTMENT HAS OCCURRED OR BEEN SCHEDULED. AS THE MANUFACTURER, IF WE RECEIVE FURTHER UPDATES, WE WILL ADD ADDITIONAL DETAIL TO THIS REPORT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20706048 ↗
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- Edge File SX7200621RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.