MAUDE Adverse Event Report: ULTRADENT PRODUCTS, INC. ENDOREZ; ROOT CANAL FILLING RESIN

Model Number 5900

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/02/2013

Event Type  Injury  

Event Description

Ultradent received a letter from maude stating the following had been reported: root canal over fill of tooth #29 into inferior alveolar nerve canal and its ascending anterior loop.Preoperative diagnoses.Right inferior alveolar nerve injury.Tight netal nerve injury was foreign body present.Operative procedures: neuroplasty of th right inferior alveolar nerve and metal nerve.Exploration of right inferior alevolar and metal nerves.Removal of foreign body and material, right inferior alveolar and mental nerve.This is a refile from 2013.

• Brand Name: ENDOREZ
• Type of Device: ROOT CANAL FILLING RESIN
• Manufacturer (Section D): ULTRADENT PRODUCTS, INC.; 505 west 10200 south; south jordan UT 84095
• Manufacturer (Section G): ULTRADENT PRODUCTS, INC.; 505 west 10200 south; south jordan UT 84095
• Manufacturer Contact: rona murphy ; 505 west 10200 south; south jordan, UT 84095 ; 8015534529
• MDR Report Key: 7125072
• MDR Text Key: 95178867
• Report Number: 1718912-2017-00035
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• PMA/PMN Number: K071106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 5900
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 100