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

Catalog Number	ASSY-500018
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional 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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that aspen motto nontemplate aligner arch that was used by a patient for treatment allegedly the patient started having minor allergic reaction to the aligners.Symptoms included an itchy and sore throat, as well as throat swelling.Reportedly, this started when the patient first began treatment and worsening around week 26 of aligner therapy.After discontinuation of aligner therapy, the symptoms resolved right away.The dental practice uses vinyl, power free exam gloves in their office.The patient did not seek additional medical treatment.
Additional Manufacturer Narrative
Investigation results: evidence: in the evidence provided by the customer (allergic reaction checklist), the patient declares not to suffer from any type of allergy.It also declares that it has not tested the patient for an allergic reaction to the product.Dhr evaluation: we reviewed the dhr for this (b)(6) / patient id# (b)(6) / practice id# (b)(6) qty.(b)(4) items assy-500018 (aligners), and (b)(4) items assy-500017 (template), were packaged by the first shift by bag and box operation on october 10, 2023, manufacturing cell 3, equipment bag-5.The sales order was inspected and met with the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this (b)(6).· raw material: part-70125-b / lot# 07431012 / qty.Received = (b)(4) pcs, inspection date: august 25, 2023.· the material was found to be acceptable for use in the manufacture of the sure smile product.

• Brand Name: ASPEN MOTTO NONTEMPLATE ALIGNER ARCH
• Common Device Name: 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19263799
• Report Number: 1649995-2024-00011
• Device Sequence Number: 2608449
• Product Code: NXC
• UDI-Device Identifier: 00856379007283
• UDI-Public: 00856379007283
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ASSY-500018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT AVAILABLE
• Patient Age: 57 YR
• Patient Sex: Female