MAUDE Adverse Event Report: US ENDODONTICS, LLC. EDGEONE PLATINUM; ENDODONTIC ROTARY FILE

Model Number	EOPPRI31
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
File broke inside the tooth and was not able to be removed.The patient was referred to an endodontist for a consult.As of this date of this report, no endododontic appointment has occurred or been scheduled.As the manufacturer, if we receive further updates, we will add additional detail to this report.

• Brand Name: EDGEONE PLATINUM
• Common Device Name: ENDODONTIC ROTARY FILE
• Manufacturer (Section D): US ENDODONTICS, LLC.; 2809 w walnut street; johnson city TN 37604
• Manufacturer (Section G): US ENDODONTICS, LLC.; 2809 w walnut street; johnson city TN 37604
• Manufacturer Contact: annika lind ; 2809 w walnut street; johnson city, TN 37604
• MDR Report Key: 20706048
• Report Number: 3008857765-2024-00006
• Device Sequence Number: 9782933
• Product Code: EKS
• UDI-Device Identifier: 00819514020721
• UDI-Public: 00819514020721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EOPPRI31
• Device Lot Number: 070822208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown