M-access® K-REAMER A11MA02101012Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 J003A11MA021010121), received between Dec 8, 2025 and Dec 8, 2025 — 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.
MalfunctionDec 8, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 21MM 010 FILE BROKE DURING USE. THE PATIENT HAD NO SYMPTOMS AFTER ROOT CANAL TREATMENT AND FILLING. NO FURTHER MEDICAL OR SURGICAL TREATMENT WAS MENTIONED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23742766 ↗
Other REAMER, PULP CANAL, ENDODONTIC devices
- M-access® K-REAMER A11MA02102012MAILLEFER INSTRUMENTS HOLDING Sàrl · REAMER, PULP CANAL, ENDODONTIC4 reports
- M-access® K-REAMER A11MA02501512MAILLEFER INSTRUMENTS HOLDING Sàrl · REAMER, PULP CANAL, ENDODONTIC1 report
- M-access® K-REAMER A11MA02501012MAILLEFER INSTRUMENTS HOLDING Sàrl · REAMER, PULP CANAL, ENDODONTIC1 report
- M-access® K-REAMER A11MA02503012MAILLEFER INSTRUMENTS HOLDING Sàrl · REAMER, PULP CANAL, ENDODONTIC1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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