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

Catalog Number 00856379007023

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

In this event it is reported that a patient experienced allergic reaction of nontemplate aligner arch shortly after initial use.Patient's symptoms included irritated gums and pallet.Patient does not have a known allergy to plastic materials, however, does have a number of other known allergies.Removal of the aligner trays provide some calming/relief from the symptoms.No known additional medical intervention has required to date.Reportedly, the patient used polident to clean aligner trays.It is known that denture cleanser often contain persulfates which can cause an allergic reaction or be the source of an irritant.It is also known that a subset of the population will have an allergic response to the material used in aligner fabrication.

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.

Manufacturer Narrative

Dhr evaluation: we reviewed the dhr for this (b)(6) / patient id# (b)(6) / practice id# (b)(6) qty.(b)(4) items assy-500011 (aligners), were packaged by of third shift by auto packing operation on august 30, 2023, manufacturing supercell sc1, equipment pua-07.The sales order was inspected and met with the acceptance criteria provided by qa.We reviewed the incoming inspection record for the material used to manufacture this (b)(6).Raw material: part-501019 / lot# 231446 / qty.Received = (b)(4) rolls, inspection date: may 17, 2023.· the material was found to be acceptable for use in the manufacture of the sure smile product.Evidence: - in the evidence provided (allergic reaction checklist) the patient declares that she is allergic to some foods.- report the following symptoms when using the aligners.- consistent friction feeling, similar to a burn.Like a layer of skin has been removed, burning sensation.- declares that it has not carried out reaction tests to the product on the patient.Failure mode: allergic reaction.Root cause: no defect - no defect during manufacturing process.Conclusion code: 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: 18028506
• MDR Text Key: 326799265
• Report Number: 1649995-2023-00042
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/23/2023
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1