MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. SURESMILE RETAINER; ALIGNER, SEQUENTIAL

Catalog Number ASSY-500015

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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.

Event Description

In this event it is reported that suresmile retainer broke while in the patients mouth.The patient swallowed a piece of the plastic.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

A capa was opened to address the cracked retainer complaints that have elevated since may 2022.Based on the investigation conducted in the capa, we determined the temperature setting used on the biostar vacuum forming machines is at a much higher heating rate which could negatively affect the plastic during fabrication of retainers.

• Brand Name: SURESMILE RETAINER
• 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: 16798541
• MDR Text Key: 313855042
• Report Number: 1649995-2023-00031
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASSY-500015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/12/2023
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2022
• Type of Device Usage: A
• Patient Sequence Number: 1