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  

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.

Event Description

In this event it is reported that patient experienced an allergic reaction to the nontemplate aligner arch, including swelling of lips, itching of the face and burning sensation in the mouth.Reportedly, the onset of symptoms occurred within the 1-2 hours of aligner wear.These symptoms resolved within 3-4 days of discontinuing use.The patient does not have any previously known allergies to plastic materials.No additional medical intervention was required.

Manufacturer Narrative

Investigation: dhr evaluation: we reviewed the dhr for this (b)(6) / patient id (b)(6) / practice id (b)(4) qty.(b)(4) items assy-500011 (aligners), 1 item assy-500010 (template), were packaged by of first shift by auto bag and box operation on (b)(6) 2024, manufacturing supercell sc2, equipment pua-03.The sales order was inspected and met with the acceptance criteria provided by qa.Evidence: in the evidence provided (allergic reaction checklist), the patient declares that he suffers from allergies to codeine.The patient was not tested to detect allergies to the product.The patient does not declare to suffer from allergies to the material or components used to manufacture the aligners.

• 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: 18676716
• MDR Text Key: 335018369
• Report Number: 1649995-2024-00004
• 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: 04/29/2024

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
• Device Catalogue Number: 00856379007023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/06/2024
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1