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

Catalog Number 00856379007023

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Type  Injury  

Event Description

In this event it is reported for nontemplate aligner arch that the patient experienced an allergic reaction due to aligner wear (diarrhea, inflamed inside of lip).The patient has since discontinued aligner treatment, and no additional medical intervention was required.The patient used dish soap and water to clean their aligners, which is not a recommended cleaning method described in the instructions for use (misuse of the device).

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device will not be returned for evaluation.However, the lot number/sn# was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Manufacturer Narrative

Investigation results: in the dhr of this so not found problems or deviations reported during the manufacturing process.The record of material used in this form was reviewed; however, no problems were found in the quality of this material, it was accepted according to the normal requirements and characteristics in the incoming inspection.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: 15438493
• MDR Text Key: 300055203
• Report Number: 1649995-2022-00019
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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: 09/06/2022
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1