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

Catalog Number	00856379007023
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/15/2021
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.
Event or Problem Description
It was reported that a female patient age (b)(6) experienced lesions and pain on the soft tissue as well as on her tongue, cheeks and soft tissue one day after starting treatment with sure smile aligners.This patient does not have any known allergies, no food allergies, no drug allergies, no pet allergies, no other known allergies.There was no medical treatment as a result of the allergic reaction, the symptoms were not related to any other patient activity, vinyl gloves were used by the dentist.No cleaning solutions were used.Patient was not tested for allergies to this product.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.

• Brand Name: SURESMILE ALIGNER
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• MDR Report Key: 12418816
• Report Number: 1649995-2021-00003
• Device Sequence Number: 17698833
• Product Code: NXC
• Combination Product (Y/N): N
• PMA/510(K) Number: K171860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: 00856379007023
• Device Lot Number: 04514544
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR