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 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/order number was provided and retained-product testing and/or dhr review are the investigation is based in the manufacturing process of aligners, retainers, templates.Dhr evaluation: we reviewed the dhr for this (b)(4) / patient id# (b)(6) / practice id# 15139 qty.2 items assy-500015 (retainers), were packaged by of second shift by bag and box operation on march 18, 2023, manufacturing cell 3, equipment bag-6.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 (b)(4).Raw material: 1apl40c125-orx / lot# 06627538 / qty.Received = 25,976 pcs, inspection date: (b)(6) 2023.The material was found to be acceptable for use in the manufacture of the sure smile product.Evidence (allergic reaction checklist).In the evidence provided by the customer (allergic reaction checklist), the patient declares not to suffer from any type of allergy.The patient was not tested for allergies to the product.Conclusion: after reviewing the records generated during the manufacturing process (dhr), incoming inspection and allergic reaction checklist.We found no failure in the manufacturing process.

Event Description

In this event it is reported that a patient experienced an allergic reaction to suresmile retainer.The patient developed redness, dryness and pain in the lips after wearing the retainer.The patient used/was prescribed topical and systemic steroids, topical creams and oral rinses to help resolve the symptoms.The patient has no known allergies.

Manufacturer Narrative

Fda coding was missed in the initial report.Adding additional investigation conclusions code 50.This is a follow up report to add this additional code.

• 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: 18150813
• MDR Text Key: 328304818
• Report Number: 1649995-2023-00047
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: ASSY-500015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2023
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1