OrthoFX NiTime Aligner 013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860003321782), received between Jan 13, 2025 and Jan 13, 2025 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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."

  Patient problems: Tooth Fracture

  MAUDE report 21143243 ↗