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

Catalog Number 00856379007023

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Nasal Obstruction (2466); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/06/2022

Event Type  Injury  

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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported that a patient experienced an allergic reaction due to nontemplate aligner arch.Patient reported symptoms of congestion, nasal discharge, cough, loss of appetite which resolved in 7 days after treatment with antibiotics, mucinex and prescription allergy medication and discontinue use of aligners.It is unknown whether the aligner device in this case caused or contributed to the patient's symptoms, or if the symptoms were related to a cold or other illness.

Manufacturer Narrative

Investigation results: so-(b)(6) patient id# (b)(6) practice id# (b)(6) qty.(b)(4) item assy-500011 (aligners), and 2 item assy-500010 (template), were packaged on september 22, 2022, by of first shift by bag & box operation.We reviewed the dhr for this so-(b)(6) and not found issues or deviations during the manufacturing process, the sales order was inspected and met with the acceptance criteria provided by qa.We reviewed the instructions for use (ifu) for aligner and retainer and in the contradictions and warnings section, if the patient has a history of allergic reactions to plastics, this product should not be used.- ifu: instructions for use ¿ 0281-ifu-500544, 0281-ifu-500583: contraindications: this product is contraindicated for patients with a history of allergic reactions to plastic.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this so-(b)(6).Raw material: rt-501017 / lot# 05818961 / qty.Received = (b)(4) pcs.The inspection results of the material was found to be acceptable for use in the manufacture of the suresmile product.Evidence provided.We reviewed the document and found that the customer declared not allergic reactions but in other section declare that the patient not tested for allergies to the product.Conclusion: no failure found patient outcome update: the patient didn't tell us about it right away because she was not sure where the reaction was coming from.Also, when she did let us know about the reaction she was having she wanted to give it a little more time before she stopped using the trays.She really wanted to straighten her teeth and she was hoping that her symptoms were not from the trays.But after several weeks and trying different allergy medications with no improvement she decided to finally stop wearing the trays.When she did this, her symptoms started to improve right away.Now after not having trays in for a couple of weeks her symptoms are totally gone.

• 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
• MDR Report Key: 15986513
• MDR Text Key: 305503946
• Report Number: 1649995-2022-00023
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2022
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1