MAUDE Adverse Event Report: ORTHOFX ORTHOFX NITIME ALIGNERS; CLEAR ALIGNERS

Model Number	013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All internal documentation shows there was not an issue with the device and as reported the dentist and patient ordered 2nd device.In addition, neither the patient nor the treating dentist have been responsive to a month of repeated contact attempts by multiple parties.This indicates the device was not likely the causative item for the suspected reported injury.
Event or Problem Description
A product review was posted on yotpo as follows: "product review disappointed.The orthofx experience has not been great.Before starting orthofx, i had trouble finding data around what the tooth fracture rates were for patients.My dentist assured me that in his experience he did not see this much.Since first 20 week set of trays i had one tooth pulled and i had another tooth that required a crown when it sheared after a visit with the dentist at the halfway point.After 20 weeks my bottom teeth are crooked and do not look at all like the simulations.A new set of trays were ordered before the holidays and they have still not come in.In addition, after week 20, my dentist and i had a real heart to heart conversation about my disappointment.During that visit i learned that orthofx should have started some sort of monitoring by me taking pictures with my cell phone on a periodic basis.I was never prompted to do this.Seems to me orthofx is more concerned about upfront payments then addressing concern of end user- patients like me.".

• Brand Name: ORTHOFX NITIME ALIGNERS
• Common Device Name: CLEAR ALIGNERS
• Manufacturer (Section D): ORTHOFX; 48890 milmont drive; suite 101d; fremont CA 94538
• Manufacturer (Section G): ORTHOFX; 48890 milmont drive; suite 101d; fremont CA 94538
• Manufacturer Contact: janice braddock ; 48890 milmont drive; suite 101d; fremont, CA 94538 ; 4159360006
• MDR Report Key: 21143243
• Report Number: 3015143007-2025-00001
• Device Sequence Number: 18414251
• Product Code: NXC
• UDI-Device Identifier: 00860003321782
• UDI-Public: (01)00860003321782(11)240708(17)250708(10)38198309
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221537
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: 07/08/2025
• Device Model Number: 013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2024
• 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: 58 YR
• Patient Sex: Male