ProGlider PROGLIDE25Recalls & reported problems
Tulsa Dental Products LLC · ProGlider Rotary Glide Path Files 25mm · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D716PROGLIDE251), received between Mar 22, 2024 and Mar 4, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- Device Embedded In Tissue or Plaque4
- Insufficient Information3
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER 3FILE STERILE 25MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. REQUESTED FURTHER INFORMATION.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 21513529 ↗MalfunctionMar 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER 3FILE STERILE 25MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 21513489 ↗MalfunctionJul 16, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER ROTARY GLIDE PATH FILES 25 MM LENGTH BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. THE PATIENT WAS REFERRED TO AN ENDO SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19751687 ↗MalfunctionJul 12, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROGLIDER ROTARY GLIDE PATH FILES 25 MM LENGTH BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19735363 ↗MalfunctionMar 22, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROGLIDER ROTARY GLIDE PATH FILES 25 MM LENGTH FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18959419 ↗
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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.