M-access® K-FILE A12MA02101512Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
All models of M-access K-FILE (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI J003A12MA021015121), received between Aug 30, 2023 and Nov 13, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- Device Embedded In Tissue or Plaque2
- Insufficient Information1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 015, THE FILE BENT AND REPORTEDLY HAD POOR SHARPNESS. THE PATIENT EXPERIENCED PAIN. FURTHER INFORMATION REQUESTED.
Patient problems: Pain
MAUDE report 23541636 ↗MalfunctionMay 7, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21 MM 015 FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BUT ACCIDENTAL TRAUMA WAS REPORTED. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21977232 ↗MalfunctionOct 5, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT K-FILE M-ACCESS 21MM 015 FILE BROKE DURING USE. THE BROKE PART REMAINS IN THE ROOT CANAL. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17877708 ↗MalfunctionAug 30, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 21MM 015 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17649450 ↗
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
- Edge File SX7450429RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300625US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS125HTUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500421US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF321US 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 16, 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