MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. TEMPLATE ALIGNER ARCH; ALIGNER, SEQUENTIAL

Catalog Number	00856379007009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that patient experienced allergic reaction to orthodontic aligners.Patient reportedly experienced swollen face.
Additional 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.
Additional Manufacturer Narrative
Failure mode: allergic reaction.Root cause: no defect - no defect during manufacturing process.Conclusion code: no failure found.Dhr evaluation: we reviewed the dhr for this so-sr03585401 / patient id# m4g4 / practice id# 07407 qty.(b)(4) items assy-500011 (aligners) 2 items assy-500010 (templates), were packaged by of first shift by bag and box operation on august 3, 2023, manufacturing cell 6, equipment bag-12.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-sr03585401.Raw material: part-501017-b / lot# 06727705 / qty.Received = (b)(4) pcs, inspection date: may 01, 2023.The material was found to be acceptable for use in the manufacture of the sure smile product.Evidence: in the evidence provided (allergic reactions checklist) the patient declares that he suffers from an allergy to mango.Report facial and cheek swelling when wearing the aligners.The patient was not tested for allergies to the product.

• Brand Name: TEMPLATE ALIGNER ARCH
• Common Device Name: 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: 17868623
• Report Number: 1649995-2023-00039
• Device Sequence Number: 20207108
• Product Code: NXC
• UDI-Device Identifier: 00856379007009
• UDI-Public: 00856379007009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: 00856379007009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/26/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown