PROTAPER UNIVERSAL Retreatment A141220090012Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Root canal file · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI J003A1412200900121), received between Dec 4, 2023 and Dec 19, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ASSORT. 21MM *NOT CE* FILE BROKE DURING USE. THE BROKEN PART REMAINED INSIDE THE CANAL AND WAS SUCCESSFULLY REMOVED ONLY AFTER ITS POSITION WAS IDENTIFIED USING AN ENDODONTIC MICROSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23855485 ↗MalfunctionDec 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER ASSORT. 21MM *NOT CE* FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED FROM THE CANAL USING A MICROSCOPE. FURTHER INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853651 ↗InjuryDec 4, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER SHAP. 19MM/SX*NOT CE* FILE BROKE DURING USE. THE BROKEN PART REMAINED IN THE CANAL. THE PATIENT EXPERIENCED SWELLING AND PAIN. THE BROKEN PART WAS RETRIEVED 3 DAYS AFTER THE EVENT. APPROXIMATELY A WEEK AFTER THE REMOVAL THE SWELLING AND PAIN DISAPPEARED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 18255913 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- EdgeTaper SETF225US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall1 report
- Brasseler USA 5026670U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026667U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7300625RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page