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

Catalog Number V040931000000

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Because this event resulted in a serious injury, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.Root causes unknown - for the defect.This submission is being made after an acquisition and internal audit of rtd.

Event Description

In this event it was reported that a dt ligh post didn't adhere at the tooth.The dentist could not rebuilt the tooth and the tooth was extracted.

• 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: 8434549
• MDR Text Key: 139290300
• Report Number: 3001226627-2018-00003
• Device Sequence Number: 1
• Product Code: ELR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040931000000
• Device Lot Number: 247792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability