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

Catalog Number 00856379007023

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Because of tooth ur3 to become intruded instead of extruded.This event meets the criteria for reportability per 21 cfr part 803.Device will not be returned for evaluation and lot# not provided; results will be submitted as they become available.

Event Description

In this event it is reported that while using nontemplate aligner arch the patient experienced an unfavorable shift in their teeth resulting in another need to refine treatment.Root cause of the unintended tooth movement has been identified as lack of attachments and trim line of the aligners (both requested by the patient and the doctor), which caused tooth ur3 to become intruded instead of extruded.

Manufacturer Narrative

Investigation found.Therapeutic model 2, actually it is a big improvement on the alignment for upper and lower arches compared with the initial scan.Aligners were packaged on (b)(6) 2022, by of third shift by bag & box operation.- we reviewed the dhr for this patient and found no evidence of problems or deviations during the manufacturing process in the aligners stage number upper 1.- we reviewed the digital stl file: so-sr02407791-arch-001-012.Stl and it does not contain attachments or bottom cuts on the ur3 tooth and was requested with a straight trimming line.This aligner required in the sales order were manufactured according with digital files spec from sales order.No defect was found during the manufacturing process.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: 15275602
• MDR Text Key: 298420527
• Report Number: 1649995-2022-00016
• 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: 09/08/2022

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?: Yes
• 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?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1