MAUDE Adverse Event Report: RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) DT LIGHT POST; POST, ROOT CANAL

Catalog Number V861961000101

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury was reported, there has been a previous report received where breakage resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The broken post may probably due to an excessive force when cutting or using dull instrument.It is recommended to cust fibre posts with a diamond coated disc or a diamond bur.This submission is being made after an acquisition and internal audit of rtd.

Event Description

It was reported that a dt light post broke during the cut of the post, before inserting it in patient mouth.

• Brand Name: DT LIGHT POST
• Type of Device: POST, ROOT CANAL
• Manufacturer (Section D): RECHERCHES TECHNIQUES DENTAIRES (R.T.D.); 3 rue louis neel; st. egreve isere, 38120 ; FR 38120
• Manufacturer (Section G): RECHERCHES TECHNIQUES DENTAIRES (R.T.D.); 3 rue louis neel; st. egreve isere, 38120 ; FR 38120
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8434544
• MDR Text Key: 139321581
• Report Number: 3001226627-2016-00002
• Device Sequence Number: 1
• Product Code: ELR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V861961000101
• Device Lot Number: 61412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1