M-access® HEDSTROEM FILE A16MA02503012Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J003A16MA025030121), received between Dec 3, 2025 and Dec 3, 2025 — classified as 1 injury.
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. 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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A HEDSTROEM M-ACCESS 25MM 030 FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED. THE PATIENT HAD COMPLAINTS OF PAIN AND SORENESS WHEN THEY BIT DOWN ON TEETH. PATIENT WAS OBSERVED FOR A MONTH, AFTER A MONTH OF FOLLOW UP THE SORENESS DISAPPEARED AND THERE WAS NO DISCOMFORT AFTER ROOT CANAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707863 ↗
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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.
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