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

Model Number	570-1422
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ortho organizers, inc.Received a complaint on (b)(6) 2021 from (b)(6) in (b)(6), nv regarding a patient who experienced tooth fracture during treatment with the reveal clear aligners.Ortho organizers requested the device for evaluation, but it was not received in time for this report.For this reason, conclusions about causality are not able to be drawn at this time.The investigation will be re-opened if the device in question is returned.
Event or Problem Description
The patient advised the doctor's office that her teeth have chipped during treatment with the reveal clear aligners.The complaint and supporting documentation state that the (b)(6)-year old patient reported to the doctor's office that her lower teeth had chipped after the first aligner tray was switched.She reported that upper tooth #8 chipped on inside corner and lower tooth # 25 chipped on top of occlusal margin due to the tooth movement after wearing the aligners for only a few weeks.The returned questionnaire did not indicate whether the patient wore the aligners at the time.In a letter submitted by the patient, she described that - after two weeks of wearing the aligners - her upper teeth would hit her lower teeth when she removed the aligners to eat.She went on to say that one week later two of her teeth had chipped.While the patient did not specifically mention this, it can be reasonably assumed that her teeth chipped after she removed the aligners and while she was eating.

• Brand Name: REVEAL CLEAR ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston ave; carlsbad CA 92008
• Manufacturer (Section G): CLEARPATH ORTHODONTICS; 6-n main boulevard; johar town; lahore, punjab 54000 ; PK 54000
• Manufacturer Contact: wendy garman ; 1822 aston ave; carlsbad, CA 92008 ; 7604488600
• MDR Report Key: 12833494
• Report Number: 2081322-2021-00001
• Device Sequence Number: 4353434
• Product Code: NXC
• UDI-Device Identifier: 00190707089788
• UDI-Public: 00190707089788
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K162609
• 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): 11/17/2021

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: 570-1422
• Device Catalogue Number: 570-1422
• Device Lot Number: HD11745
• 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: 10/21/2021
• Initial Report FDA Received Date: 11/17/2021
• 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: Disability
• Patient Age: 70 YR
• Patient Sex: Female