M-access® K-FILE A12MA02501012Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI J003A12MA025010121), received between Nov 21, 2023 and Dec 8, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break10
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions5
- Device Embedded In Tissue or Plaque2
- Tooth Loss1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 FILE BENT AND DEFORMED DURING USE. THIS RESULTED IN INCOMPLETE TREATMENT AND THE PATIENT CAN ONLY HAVE THE TOOTH EXTRACTED. FURTHER INFORMATION REQUESTED.
Patient problems: Tooth Loss
MAUDE report 23743745 ↗MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS LEFT IN THE CANAL. FURTHER INFORMATION RECEIVED THAT THE BROKEN PART HAS BEEN REMOVED BY ANOTHER HOSPITAL. THE PATIENT IS FINE NOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742953 ↗MalfunctionNov 12, 2025Break; Break
IN THIS EVENT, IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BY MICROSCOPE AND ULTRASONIC EQUIPMENT. CONTINUING WITH SUBSEQUENT TREATMENT. PATIENT INFORMATION PENDING. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23533197 ↗MalfunctionSep 19, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25 MM 010 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23095997 ↗MalfunctionJun 11, 2025Break; Break
IN THIS EVENT, A K-FILE M-ACCESS BROKE DURING USE AND FELL IN MOUTH. THE OUTCOME OF THE EVENT IS NOT KNOWN AS OF THIS MDR EVALUATION. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22188718 ↗MalfunctionMay 27, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND LEFT IN THE CANAL. CONTACT MADE WITH DENTIST OFFICE FOR FURTHER INFORMATION, DENTIST STATED THIS HAPPENED IN 2022 AND THEY DO NOT REMEMBER INJURY OR NOT. THERE WAS NO INJURY MENTIONED IN THE REPORT AND NO FURTHER TREATMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22086788 ↗MalfunctionMay 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 FILE BROKE DURING USE. REPORTEDLY, THE BROKEN PART WAS RETRIEVED BUT FURTHER INFORMATION REGARDING POTENTIAL PATIENT INJURY IS PENDING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22063494 ↗MalfunctionMay 7, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 010 BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BUT ACCIDENTAL TRAUMA OCCURRED. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21977001 ↗MalfunctionJul 17, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT K-FILE M-ACCESS 25MM 010 BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19762144 ↗MalfunctionNov 21, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT K-FILE M-ACCESS 25MM 010 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18181781 ↗
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- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026664U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7200621RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFPRI21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350431US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.