ProTaper Gold Rotary File PTGRS125Recalls & reported problems
Tulsa Dental Products LLC · ProTaper Gold Rotary S1 25mm · Class 1
All models of ProTaper Gold Rotary File (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI D716PTGRS1251), received between Jan 2, 2024 and May 27, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Break” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break13
Patient problems
- Device Embedded In Tissue or Plaque11
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 25MM FILE BROKE DURING USE. THE BROKEN PART WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299054 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F3 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853971 ↗MalfunctionSep 3, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD S1 25MM STER FILE BROKE DURING USE. THE BROKEN PART AS NOT RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22950467 ↗MalfunctionJul 7, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD S1 25MM STER FILE BROKE DURING USE. THE BROKEN PART LOCATED IN THE CANAL OF #26 COULD NOT BE RETRIEVED. A ROOT-END RESECTION MAY BE NECESSARY FOR TOOTH 26. THE PATIENT WAS NOT INJURED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22413811 ↗MalfunctionMay 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 25 MM FILE BROKE DURING USE. 2 MM OF THE TIP AT THE APEX IN TOOTH #31. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY. CASE 2 OF 2.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22104183 ↗MalfunctionMay 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 25MM FILE BROKE DURING USE. THE BROKEN PART OF THE TIP AT THE APEX IN TOOTH #24. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY. CASE 1 OF 2.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22104148 ↗MalfunctionMay 2, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD ROTARY S1 25MM BROKE DURING USE. THE DOCTOR WAS UNABLE TO RETRIEVE OR BYPASS TO COMPLETE THE PROCEDURE. A TEMPORARY CROWN WAS INSTALLED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19231011 ↗MalfunctionMay 2, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 25MM BROKE DURING USE. DOCTOR WAS ABLE TO BYPASS AND COMPLETE THE PROCEDURE. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19230976 ↗MalfunctionMay 2, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 25MM BROKE DURING USE. DOCTOR WAS ABLE TO BYPASS AND COMPLETE THE PROCEDURE. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19230914 ↗MalfunctionMar 21, 2024Break; Break
IN THIS EVENT IT IS REPORTED PROTAPER GOLD ROTARY S1 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. PATIENT IS BEING WATCHED FOR ANY ADVERSE EFFECTS, CURRENTLY THEY RE ASYMPTOMATIC. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18948901 ↗MalfunctionJan 23, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD S1 25MM STER FILE BROKE DURING USE. THE BROKEN PARTS COULD NOT BE RETRIEVED. PATIENT REFERRED TO ENDO SPECIALIST. FURTHER TREATMENT PENDING. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18563724 ↗MalfunctionJan 23, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD S1 25MM STER BROKE DURING USE. THE BROKEN PARTS STILL REMAIN IN THE ROOT CANAL. PATIENT(S) REFERRED TO AN ENDO SPECIALIST TO REMOVE BROKEN PARTS. FURTHER INFORMATION REQUESTED FOR THE OUTCOME ON PENDING TREATMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18562594 ↗MalfunctionJan 2, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD S1 25MM STER BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18424486 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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