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 Date 04/21/2023

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

Event Description

In this event it is reported that a patient had an allergic reaction to nontemplate aligner arch.The gum tissue became inflamed in the area where the aligners have contact with the gums.The outcome is unknown as of this mdr.Further information requested.

Manufacturer Narrative

We reviewed the dhr for this (b)(6) / patient id#: (b)(6), qty.(b)(4) items assy-500011 (aligners) and 2 item assy-500010 (template), were packaged on august 31, 2022, by of first shift by bag & box operation.Not found issues or deviations during the manufacturing process, the sales order was inspected and met with the acceptance criteria provided by qa.Instructions for use (ifu).We reviewed the instructions for use (ifu) for aligner and retainer and in the warnings section, if the patient has a history of allergic reactions to plastics, this product should not be used.Doctor instructions for use: 0281-ifu-500544.Patient instructions for use: 0281-ifu-500583.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this (b)(6).Raw material: part: 501017 / lot#: 5818961 / qty.Received (b)(4), (b)(4) pcs.The inspection results of the material were found to be acceptable for use in the manufacture of the suresmile product.Root cause: no defect in manufacturing process.Conclusion code: 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: 16814198
• MDR Text Key: 313991398
• Report Number: 1649995-2023-00032
• 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: 05/26/2023

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: 00856379007023
• Device Lot Number: 06030673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/21/2023
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female