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 a patient experienced an allergic reaction during the wearing of nontemplate aligner arch.The patient experienced burning tongue, inflamed taste buds, itching and tender and swollen gums.Reportedly, the patient has a known allergy to plastic materials.Symptoms resolved about 4 days after discontinuing aligner use.Medical intervention was not necessary.

Manufacturer Narrative

Dhr evaluation: we reviewed the dhr for this so-sr03462371 / patient id# (b)(6) / practice id# (b)(6) qty.(b)(4) items assy-500011 (aligners) 2 items assy-500010 (template), were packaged by of first shift by bag & box (bag-16) date: june 14, 2023, not found issues or deviations during the manufacturing process, the sales order was inspected and met with the acceptance criteria provided by qa.The sales order was manufacturing in super cell sc0.The instructions for use (ifu) for aligner and retainer and in the warnings section, if the patient has a history of allergic reactions to plastics, this product should not be used.Digital file review: file is good.Other investigation: incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this so-sr03462371.Raw material: part-501019 / lot# 230183 / qty.Received = (b)(4) rolls, inspection date: may 17, 2023.Rt-70125-b / lot# 06925904 / qty.Received =(b)(4) pcs, inspection date: april 20, 2023.The material was found to be acceptable for use in the manufacture of the sure smile product.

• 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: 17549096
• MDR Text Key: 321162481
• Report Number: 1649995-2023-00036
• 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: 08/21/2023

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: 08/01/2023
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1