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

Catalog Number 00856379007023

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The patient has a moderated crowding on the lower arch, all the dental movements area applied according the dl protocol.The movements were compensated to maintain the roots as close as possible to the reference model.Ipr was prescribed to help with the unraveling.We did not have pictures or x-rays to follow, dr submitted fake pictures to fulfill the requirement.The mobility is a common issue with aligner therapy, the dr probably doesn't have enough experience dealing with moderate aligner cases.We can offer a call with the doctor(s) to help him with the case.No defect proven/no failure found.

Event Description

In this event it is reported that a nontemplate aligner arch, patient experienced tooth instability due to aligner wear.Treatment has been discontinued.

Manufacturer Narrative

The patient has a moderated crowding on the lower arch, all the dental movements area applied according the dl protocol.The movements were compensated to maintain the roots as close as possible to the reference model.Ipr was prescribed to help with the unraveling.We did not have pictures or x-rays to follow, dr submitted fake pictures to fulfill the requirement.The mobility is a common issue with aligner therapy, the dr probably doesn't have enough experience dealing with moderate aligner cases.We can offer a call with doctor to help him with the case.No defect proven/no failure found.

• 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: 15679486
• MDR Text Key: 302477780
• Report Number: 1649995-2022-00021
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/12/2022
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention