MAUDE Adverse Event Report: ORTHOFX ORTHOFX ALIGNER; DENTAL ALIGNER

Model Number	SMYLIO CLEAR ALIGNER
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported having a previous set of aligners with sharp edges that caused an infection and received antibiotics due to the infection.A manager within the smylio customer success team manager, "m", contacted the patient on (b)(6), 2023 to request additional information regarding the infection they experienced and whether or not they received medical intervention.On (b)(6), 2023, customer success team member k posted on the salesforce complaint record that patient a communicated that their medical doctor prescribed amoxicillin 875 mg on (b)(6), 2023 for the reported infection.Thus, on (b)(6), this complaint was deemed reportable because the patient notified the cs team that she received medical intervention.Following the report of the infection, the customer success team continued to stay in contact with the patient.The patient was no longer experiencing issues with the infection.The patient contacted the cs team on (b)(6), stating that they received their replacement aligners at their doctor's office and the doctor assisted with making a few modifications, such as filing the aligners down.The patient confirmed that the new aligners were not causing any additional issues.On (b)(6), the patient notified the cs team that the new aligners were not presenting any issues.On (b)(6), the patient reached out to the cs team to notify them that they were proceeding with treatment and not experiencing any issues.On june 15th the patient reached out to the cs team for information regarding their account and plan information so the patient could pay for their treatment in full.The patient confirmed that they are not experiencing any additional issues and want to continue with the orthofx orthodontic treatment.The cs team performed one final follow up on (b)(6), 2023, where the patient notified the cs team that they are happy with their product.As on (b)(6), 2023, the patient complaint case has been resolved with no further complications.
Additional Manufacturer Narrative
Patient reported infection due to discomfort with aligner edges.Patient had discarded aligner prior to contacting orthofx.Orthofx reviewed manufacturing records and trend analysis regarding this event; no issues were found.Aligners were replaced for good customer support.Patient was proactively contacted by customer service to assess and help resolve all complaint issues.

• Brand Name: ORTHOFX ALIGNER
• Common Device Name: DENTAL ALIGNER
• Manufacturer (Section D): ORTHOFX; 48890 milmont dr #101d; fremont CA 94538
• Manufacturer Contact: karla hernandez ; 48890 milmont dr #101d; fremont, CA 94538 ; 4159360006
• MDR Report Key: 17408624
• Report Number: 3015143007-2023-00001
• Device Sequence Number: 6093475
• Product Code: NXC
• UDI-Device Identifier: 00860003321706
• UDI-Public: 00860003321706
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: Health Professional
• Device Expiration Date: 12/26/2023
• Device Model Number: SMYLIO CLEAR ALIGNER
• Device Catalogue Number: SMY-001
• Device Lot Number: 2205-226
• 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: 05/23/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White