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

Catalog Number ASSY-500015

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/24/2023

Event Type  Injury  

Event Description

In this event it is reported that patient experienced an allergic reaction to wearing of suresmile retainer.The patient has been in suresmile aligners for a number of months, and now, every time she puts the aligners in, she gets a burning sensation on her tongue and lips.Whenever she leaves them out, she does not get these symptoms.

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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Investigation: dhr evaluation: we reviewed the dhr for this so-(b)(6) / patient id# (b)(6).Qty.(b)(4) items assy-500015 (retainers), were packaged by of third shift by bag and box operation on july 28, 2023, manufacturing cell 6, equipment bag-16.The sales order was inspected and met with the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this so-(b)(6).Raw material: 1apl40c125-orx / lot# 07058839 / qty.Received = (b)(4) pcs, inspection date: june 29, 2023.· the material was found to be acceptable for use in the manufacture of the sure smile product failure mode: allergic reaction root cause: no defect conclusion code: no failure found.

• Brand Name: SURESMILE RETAINER
• 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: 18147794
• MDR Text Key: 328265158
• Report Number: 1649995-2023-00044
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASSY-500015
• Device Lot Number: 07391803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2023
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Sex: Female