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

Model Number	BYTERETAINERTRAY
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that a patient using the suresmile retainer experienced having an anterior open bite, the retainer did not fit.The doctor rescanned the patient and will submit a new order for the retainer.
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event 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.

• 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: 24755521
• Report Number: 1649995-2026-00009
• Device Sequence Number: 12947554
• Product Code: KMY
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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?: Yes
• Device Model Number: BYTERETAINERTRAY
• Device Catalogue Number: ASSY-500015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/30/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown