NA 401.306Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20887587046713), received between Oct 11, 2022 and Oct 11, 2022 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 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 ORTHOGNATHIC IMPLANTS OF THE ATTACHED INVOICE IN (B)(6) 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 METALLOSIS IN THE REGION WHERE THE IMPLANTS WERE AND NO APPARENT INFECTION. THIS REPORT IS FOR ONE (1) 2.4MM TI EMERGENCY SCREW 6MM-5PK. THIS IS REPORT 6 OF 16 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15583924 ↗
• 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 (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE PATIENT IMPLANTED THE ORTHOGNATIC IMPLANTS OF THE ATTACHED INVOICE IN (B)(6) 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) 2.4MM TI EMERGENCY SCREW 6MM-5PK. THIS IS REPORT 7 OF 16 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15583415 ↗