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

Catalog Number 00856379007023

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)

Event Date 01/24/2023

Event Type  Injury  

Event Description

In this event it is reported the patient experienced an allergic reaction after starting to wear nontemplate aligner arch.The patient reportedly experienced swelling and redness inside the mouth and pain in the gums.The patient has discontinued aligner treatment and symptoms resolved within 2 weeks.It was also reported that the patient was prescribed amoxicillin for 1 week at a dose of 00 mg, 4x/day.No known additional medical intervention was required.

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: we checked the dhr (so- (b)(6) patient id# (b)(6) practice id#: (b)(6)) the evidence not present problems o deviations in the manufacturing process, all process was completed conformed the wi & the items were shipped to the customer without problems.We reviewed the raw material used (05950836) in this so.In the record of raw material no found reported of problems of quality in the inspection.Root cause: no defect; conclusion: no failure found.

• 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: 16282846
• MDR Text Key: 308617075
• Report Number: 1649995-2023-00026
• 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: 02/13/2023

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 Operator: Health Professional
• Device Catalogue Number: 00856379007023
• Device Lot Number: 06168334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/24/2023
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female