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  

Event Description

The patient experienced an allergic reaction to orthodontic aligners, including swelling of the lips, gingiva, perioral tissue and face.The patient also experienced intraoral tingling.Onset of symptoms occurred within the first 24-36 hours of aligner wear and resolved within 3-4 days of discontinuing use.No additional medical intervention was required.The patient has known allergies to erythromycin, penicillin, sulfa drugs, tree pollen, grasses, smoke, perfume/fragrance, hay and latex.The dental practice does not use latex gloves in their office.The patient does not have any previously known allergies to plastic materials.

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 results: dhr dhr evaluation: we reviewed the dhr for this (b)(6) / patient id#: (b)(6) / practice id#: (b)(6) qty.(b)(4) items assy-500011 (aligners), (b)(4) items assy-500010 (template), were packaged by of third shift by bag and box operation on february 24, 2024, manufacturing cell 7, equipment bag-11.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)(6).Raw material: part: 501017-b / lot#: 7747535 / qty.Received = (b)(4) pcs, inspection date: january 11, 2024.The material was found to be acceptable for use in the manufacture of the sure smile product.Other evidence: in the evidence provided (allergic reaction checklist), the patient declares that he suffers from allergies to some medications (erythromycin, penicillin, sulfadrugs), and others (tree pollen, grasses, smoke, latex, most perfume, chemical scents, hay).The patient was not tested to detect allergies to the product.Additional: product has not been returned after 27 days.Follow-up was sent with no reply.A subset of the population is known to have an allergic reaction to the aligner material.There isn't a test to do on the actual product for allergic reaction so return product is not needed.Dhr and raw material inspections will be reviewed for any deviations in the manufacturing or raw material.

• 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: 19039917
• MDR Text Key: 339325334
• Report Number: 1649995-2024-00008
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/25/2024

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: 00856379007023
• Device Lot Number: F10300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2024
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1