MAUDE Adverse Event Report: Dentsply Sirona Orthodontics Inc. - Richardson SURESMILE RETAINER; positioner, tooth, preformed

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Code	Headache (1880)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a suresmile retainer caused gaps in patients lower teeth which also led to headaches.Patient's headache and gaps have been resolved by ordering new trays.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.

• Brand Name: SURESMILE RETAINER
• Common Device Name: positioner, tooth, preformed
• Manufacturer (Section D): Dentsply Sirona Orthodontics Inc. - Richardson; 2350 campbell creek blvd; richardson TX 75082
• Manufacturer Contact: dan edgar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50421600
• Report Number: 1649995-2026-00534
• Device Sequence Number: 10404858
• Product Code: kmy
• UDI-Device Identifier: 00856379007269
• UDI-Public: 00856379007269
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown