FDA Adverse Event
Injury
Summary report: N
EXACT TAPER
MDR report key: 23025753
·
Received September 11, 2025
Report
- Report Number
- 2245654-2025-00013
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- July 21, 2025
- Report Date
- September 11, 2025
- Manufacturer
- SS WHITE BURS LLC
- Product Code
- EKS
- UDI-DI
- D690TTHF3252
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIAGTION DUE TO THE FILE REMAINING IN THE PATIENTS TOOTH. HOWEVER, AN INVESTIGATION WAS PERFORMED USING A DIFFERENT LOT NUMBER AND THE RESULTS OF THE 12-PIECE SAMPLE SHOWED TO BE ABOVE SPECIFICATIONS.
Description of Event or Problem · 0
DURING A DENTAL PROCEDURE ON (B)(6) 2025, AN ENDODONTIC FILE BROKE ON INITIAL INSERTION OF FILE. THE FILE BROKE OFF ABOVE THE CUTTING FLUTE WHICH RESULTED IN THE FILE REMAINING IN THE PATIENTS TOOTH. SS WHITE BURS WAS MADE AWARE OF THIS INCIDENT ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2192765 | EXACT TAPER | FILE, PULP CANAL, ENDODONTIC | EKS | SS WHITE BURS LLC | UTTHF325 | L04F | D690TTHF3252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male | Other |