Skip to content

TRANSFORCE TRANSVERSE 424-532Recalls & reported problems

Ortho Organizers, Inc. · TRANSFORCE TRANSVERSE ARCH DEVELOPER SIZE 32mm · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190707060008), received between Oct 16, 2020 and Oct 16, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    INCIDENCE OCCURRED IN (B)(6) WHERE AN ARM OF A TRANSFORCE APPLIANCE (ORTHODONTIC ATTACHMENT) WAS BROKEN OFF OF THE TOOTH AND SWALLOWED BY THE PATIENT WHILST SLEEPING. X-RAY CONFIRMED THAT THE ROD WAS SWALLOWED AND IS STILL IN THE PATIENT'S BODY. COMPLAINT SENT TO ORTHO ORGANIZERS, INC. ON DECEMBER 6TH 2019.

    Patient problems: Foreign Body In Patient

    MAUDE report 10693787 ↗

Other BRACKET, METAL, ORTHODONTIC devices

All BRACKET, METAL, ORTHODONTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.