MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. NONTEMPLATE ALIGNER ARCH; ALIGNER, SEQUENTIAL

Catalog Number 00856379007023

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023); Unintended Movement (3026)

Patient Problem Sensitivity of Teeth (2427)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device caused or contributed to this issue, the event meets the criteria for reportability per 21 cfr part 803.The device will not be returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Additional information will be submitted when received.

Event Description

In this event it is reported while using non-template aligner arch patient experienced increased sensitivity and mobility of tooth #8.Patient advised to stop use of aligners.Patient to return for follow up and additional information will be forth coming.

Manufacturer Narrative

The case was reviewed by the digital lab (dl) manager and dr.(b)(6).The practice (dentist) did not provide a pano scan prior to treatment planning, nor did they provide any indication that the patient already had shortened tooth roots.The practice did not request reduced movement constraints for each aligner series/tray, a scalloped trimline or passive aligners during the treatment plan.The digital lab provides a service to the dentist to aid in the treatment planning process.The clinical integrity and approval of the treatment plan is solely the responsibility of the prescribing dentist.Furthermore, the instructions for use provided with suresmile aligners state the aligners are to be worn for 20-22 hours per day, and each series/tray should be worn for at least 2 weeks.The practice did not request or disclose their intent to have the patient wear the aligners for less hours per day.Therefore the result of our investigation concludes off-label use by the prescribing dentist.

• Brand Name: NONTEMPLATE ALIGNER ARCH
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15275259
• MDR Text Key: 298395199
• Report Number: 1649995-2022-00015
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/12/2022
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1