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

Catalog Number 00856379007009

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

In this event it is reported that a patient experienced an allergic reaction while wearing template aligner arch.The patient received cortisone to treat the reaction.

Manufacturer Narrative

Dhr evaluation: we reviewed the dhr for this (b)(4), patient id# (b)(6), practice id# (b)(4) qty.(b)(4)items assy-500011 (aligners) 2 items assy-500010 (template), were packaged by of first shift by bag & box (bag-11) date: (b)(6) 2022, not found issues or deviations during the manufacturing process, the sales order was inspected and met with the acceptance criteria provided by qa.The sales order was manufacturing in traditional cell 6 is not super cell.For manufactured the sale order (b)(4) used laser marking & trimming ltu & lmu-13.The items of sales order weren¿t applied manual blockout using pink putting since the printing process to obtain the arches was performed on (b)(6) 2022, and the pink putting material was release to production at (b)(6) 2023.Raw material: resin used: dpr-10, lot # vfh7285.Part-501017-b essix ace plastic 0.30 cl pctg 125mm circle bulk, lot: 06014619.Rt-70125-b essix tray rite 125mm circle.020in, lot: 05950926.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.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this (b)(4).Raw material: rt-501017-b, lot# 06014619, qty.Received = (b)(4) pcs, inspection date: october 14, 2022.The material was found to be acceptable for use in the manufacture of the sure smile product.Photo investigation evidence.Photo evidence provided by the customer shows the issue of the alleged event.The customer did not provide an allergic reaction checklist for this case.Conclusion: with the evidence available reviewed, records generated during the manufacturing process (dhr) and incoming inspection, we found not any deviation in the process that potentially cause the allergy reaction.Failure mode: allergic reaction.Root cause: not determined - with the evidence available reviewed, records generated during the manufacturing process (dhr) and incoming inspection, we found not any deviation in the process that potentially cause the allergy reaction.Conclusion code: indeterminable.

• Brand Name: TEMPLATE 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: 17549222
• MDR Text Key: 321159205
• Report Number: 1649995-2023-00037
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007009
• UDI-Public: 00856379007009
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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: 08/03/2023
• Date Manufacturer Received: 08/03/2023
• Type of Device Usage: A
• Patient Sequence Number: 1