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 had an allergic reaction to the nonteplate aigner arch.The patient was just in the beginning of the treatment when their symptoms began.They experienced severe migraines, nausea, neck and jaw pain.The patient had a lengthy conversation with the doctor and the doctor decided to end treatment due to this adverse reaction.Further information requested.

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.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19200302
• MDR Text Key: 341240610
• Report Number: 1649995-2024-00010
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/25/2024
• Date Manufacturer Received: 04/25/2024
• Type of Device Usage: A
• Patient Sequence Number: 1