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

Catalog Number 00856379007023

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case was in fact suresmile aligner or if it 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 Description

It was reported that the patient experienced headache, neck pain, elevated blood pressure and rapid heart rate after starting aligner treatment.It is unknown whether or not the symptoms resolved after aligner use was discontinued.No additional medical intervention was required.The patient does not have any known allergies, however it a subset of the population will have an allergic response to the material used in aligner fabrication.The dentist declined to complete the allergic reaction checklist.The cardiologist stated that the aligners were invisalign brand, however we do have this patient as a suresmile aligner customer in our system.

Manufacturer Narrative

While it is unknown if the device used in this case was in fact suresmile aligner or if it 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 Description

It was reported that the patient experienced headache, neck pain, elevated blood pressure and rapid heart rate after starting aligner treatment.It is unknown whether or not the symptoms resolved after aligner use was discontinued.No additional medical intervention was required.The patient does not have any known allergies, however it a subset of the population will have an allergic response to the material used in aligner fabrication.The dentist declined to complete the allergic reaction checklist.The cardiologist stated that the aligners were invisalign brand, however we do have this patient as a suresmile aligner customer in our system.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• 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: 12959990
• MDR Text Key: 286007741
• Report Number: 1649995-2021-00005
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00856379007023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2021
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other