MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. REVEAL CLEAR ALIGNERS; SEQUENTIAL ALIGNERS

Model Number	140-8735
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported he tried to wear the step 1 maxillary tray for 2-3 days, but discontinued because of jaw pain despite taking ibuprofen.He was able to tolerate the lower tray.According to the doctor's office, they initially instructed the patient not to bite the trays in at insertion.The patient thought he should not be biting at all while wearing the aligners, so he kept opening his mouth.According to the doctor's office, this could have contributed to tmj pain.He tried to wear the trays again, but couldn't because of soreness around his teeth.
Additional Manufacturer Narrative
The customer complaint form and patient questionnaire regarding the reveal aligners standard state that the 42-year-old male patient was seen after attachment debonded from tooth #13.Patient reported he tried to wear the step 1 maxillary tray for 2-3 days, but discontinued because of jaw pain despite taking ibuprofen.He was able to tolerate the lower tray.According to the doctor's office, they initially instructed the patient not to bite the trays in at insertion.The patient thought he should not be biting at all while wearing the aligners, so he kept opening his mouth.According to the doctor's office, this could have contributed to tmj pain.He tried to wear the trays again, but couldn't because of soreness around his teeth.As stated in the patient questionnaire, no hospital visit was indicated, no follow-up or prescription medications were required, and the patient has fully recovered.Due to a possible vps impression discrepancy, it was suggested to remove the attachments and redo impressions.Ortho organizers decided to report this complaint to the fda because the patient took otc medication (ibuprofen) and attachments were removed to redo impressions.

• Brand Name: REVEAL CLEAR ALIGNERS
• Common Device Name: SEQUENTIAL ALIGNERS
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave.; carlsbad CA 92008
• Manufacturer (Section G): BRASSELER; 1 brasseler blvd.; savannah GA 31419
• Manufacturer Contact: nicole rajek ; 1822 aston ave.; carlsbad, CA 92008 ; 7604488600
• MDR Report Key: 17852343
• Report Number: 2081322-2023-00004
• Device Sequence Number: 19680675
• Product Code: NXC
• UDI-Device Identifier: 00190707096946
• UDI-Public: 00190707096946
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K210613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/02/2023

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: Other
• Device Model Number: 140-8735
• Device Catalogue Number: 140-8735
• 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: 09/21/2023
• Initial Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male