MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. SURESMILE RETAINER; POSITIONER, TOOTH, PREFORMED

Catalog Number	ASSY-500015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable 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 or Problem Description
In this event it is reported that while a patient using the suresmile retainer chipped their tooth when removing the retainers.The retainers were too tight upon insertion.The doctor placed a temporary crown and is going to rescan then order a new set when the permanent crown is placed.
Additional Manufacturer Narrative
Investigation results.Return: we received the return of 2 retainers, patient id: b9t7.We inspected the returned retainers (uret sn: (b)(6)) and found no deformations or distortions in the device trays that could cause the issue described in the reported event.The retainers meet the quality criteria specified in 0281-wi-aln-005-3 final quality control and aligner washing, visual defect detection.Dhr: we reviewed the dhr for this (b)(6) / patient id# (b)(6) qty.(b)(4) items assy-500015 (retainers) were packaged by the first shift by bag-and-box operation on (b)(6) 2025, in manufacturing cell 7, equipment bag-16.The sales order was inspected and met the acceptance criteria provided by qa.Other: dl protocol was followed.Digital models and scan data looks good.We can not add additional blockouts to a standalone retainer order.If they would additional ones added then they will need to order a full-service case.The blockouts are generated in manufacturing for the standalone retainers.

• Brand Name: SURESMILE RETAINER
• Common Device Name: POSITIONER, TOOTH, PREFORMED
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22787222
• Report Number: 1649995-2025-00056
• Device Sequence Number: 8236444
• Product Code: KMY
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ASSY-500015
• Device Lot Number: 10710110
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/11/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 9 YR
• Patient Sex: Female