MAUDE Adverse Event Report: ULTRADENT PRODUCTS INC. TILOS PATIENT MEDIUM PACK KIT; ENDO FILE

Catalog Number 7584

Device Problem Device Handling Problem (3265)

Patient Problem Discomfort (2330)

Event Date 09/03/2014

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been returned for evaluation and the outcome of the event is unknown.No further information could be obtained.Refiling due to original report not being successfully uploaded to data base.

Event Description

Dentist was working on tooth when the file broke where the twist of the file starts.Dentist tried to retrieve but was unsuccessful.The patient was refered to an endodontist.

• Brand Name: TILOS PATIENT MEDIUM PACK KIT
• Type of Device: ENDO FILE
• Manufacturer (Section D): ULTRADENT PRODUCTS INC.; 505 west 10200 south; south jordan UT 84095
• Manufacturer (Section G): ULTRADENT PRODUCTS; 505 west 10200 south; south jordan UT 84095
• Manufacturer Contact: rona murphy ; 505 west 10200 south; south jordan, UT 84095 ; 8015534529
• MDR Report Key: 7131675
• MDR Text Key: 95848025
• Report Number: 1718912-2017-00038
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 7584
• Device Lot Number: B94SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 91