PathFile PTH021321Recalls & reported problems
Tulsa Dental Products LLC · PathFile 21mm 013 · Class 1
- 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 D716PTH0213211), received between Sep 15, 2025 and Sep 15, 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.
MalfunctionSep 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PATHFILE 21MM 013 FILE BROKE DURING USE. THE BROKEN PART HAS NOT BEEN RETRIEVED, ANOTHER APPOINTMENT HAS BEEN SCHEDULED TO TRY AGAIN TO REMOVE THE BROKEN PART. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23053780 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.