NA 447.074Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587052694), received between Oct 11, 2022 and Oct 11, 2022 — 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 16, 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.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE PATIENT IMPLANTED THE ORTHOGNATIC IMPLANTS OF THE ATTACHED INVOICE IN JULY 2019. BUT 3 YEARS AFTER SHE PRESENTED A TOPICAL ALLERGY (REDNESS), THAT IS, JUST OUTSIDE, AROUND THE MOUTH REGION. THE SURGEON REPORTED THAT THE PATIENT HAS ALLERGY TO NICKEL AND CHROME. THE SURGERY FOR REMOVAL OF THE IMPLANTS HAS ALREADY BEEN PERFORMED AND THE PATIENT DID NOT PRESENT ANY METALOSIS IN THE REGION WHERE THE IMPLANTS WERE AND NO APPARENT INFECTION. THIS REPORT IS FOR ONE (1)2.0 TI CHIN PL, DBLE BEND 5 H, 6 OFFSET. THIS IS REPORT 12 OF 16 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15584227 ↗